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Conclusions | residual neuromuscular block | MINOR | Recovery of spontaneous breathing could be used as a substitute of neuromuscular monitoring to guide neostigmine use in pediatric patients following minor surgeries. However, care should be taken for the residual neuromuscular block. | PMC9824919 |
Trial registration | Chinese Clinical Trial Registry ChiCTR-IOR-17012890. Registered on 5 October 2017 | PMC9824919 |
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Keywords | PMC9824919 |
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Background | neuromuscular block, bradycardia, vomiting, nausea | ADVERSE EVENTS | Application of muscle relaxants can improve the surgery and anesthetic conditions of patients undergoing general anesthesia, and they are commonly used in the clinic [Neostigmine, which is the most commonly used antagonist of muscle relaxants in the clinic, is often used at a dose of 0.02–0.07 mg/kg. Common adverse events include bradycardia, nausea, and vomiting [Therefore, we hypothesized that recovery of spontaneous breathing could be used as a substitute of neuromuscular monitoring to guide the use of neostigmine to reverse the neuromuscular block. We aimed to evaluate the incidence of rNMB in pediatric patients with routine use of neostigmine after recovery of spontaneous breathing compared with the patients with the use of neostigmine guided by neuromuscular monitoring in this randomized, controlled noninferiority trial. | PMC9824919 |
Methods | bradycardia, hypoxia, muscle paralysis, hernia, nausea, vomiting | RESPIRATORY DISEASE, CARDIOVASCULAR DISEASE, NEUROMUSCULAR JUNCTION DISEASE, ADVERSE EVENTS, HYPOXIA, LIVER DISEASE, WEST, SECONDARY | This was a single-center, parallel, randomized, controlled trial, and was approved by the Ethics Committee of West China Hospital, Sichuan University. The study was registered in the Chinese Clinical Trial Registry (registration number: ChiCTR-IOR-17012890). The hospital that carried out this study is a research hospital in western China. This study included pediatric patients who underwent inguinal hernia repair under general anesthesia, used a muscle relaxant during surgery, had American Society of Anaesthesiologists Physical Status I–II, and were aged 3 months to 12 years. Pediatric patients with neuromuscular junction disease, cardiovascular disease, respiratory disease, or liver disease, as well as those who used drugs that may affect neuromuscular function in the past 3 months, were excluded. The parents or guardians of the involved children signed informed consent before surgery. The random number table was generated by a software program (EXCEL 2010, Microsoft, USA) and was sealed in an opaque envelope. The study was double blinded to the data collectors and the parents or guardians of the participants.Guardians were allowed to accompany their children to the operating room (OR) until the children are sedated. Hence no pre-anesthesia medication was used. Anesthesia was induced by propofol, fentanyl, and cis-atracurium, and then endotracheal intubation was performed. Sevoflurane was used for maintenance of anesthesia. An electrocardiogram, pulse oxygen saturation, non-invasive blood pressure, and end-tidal carbon dioxide were routinely monitored during surgery. The ventilator settings were 8–10 ml/kg for tidal volume, 12–20 bpm for the respiratory rate, and the ratio of inspiration time to expiration time was 1:2. Neuromuscular function of the patient was monitored immediately after induction of anesthesia, and monitoring continued until the patient exited the OR. The enrolled pediatric patients were divided into the experimental group and the control group. For children in the experimental group, 0.02 mg/kg neostigmine and 0.01 mg/kg atropine were routinely administered after recovery of spontaneous breathing. Anesthesiologists were blinded to the TOF ratio of children in the experimental group. Children in the control group were administered neostigmine under the neuromuscular monitoring guided after surgery. When the TOF ratio was between 0.4 and 0.9, 0.02 mg/kg neostigmine and 0.01 mg/kg atropine were administered. If the TOF ratio was >0.9, neostigmine and atropine were not provided. The extubation indications and the criteria for exiting the OR were under the control of the anesthesiologist who performed the anesthesia. Tidal volume, respiratory rate, end-tidal carbon dioxide, status of consciousness, and TOF ratios were recorded before extubation. After extubation, children were transferred to the post-anesthesia care unit (PACU). Children were followed up until 1 day after the surgery. The follow-up nurses were not aware of the grouping of the participants.The primary outcome was the incidence of rNMB immediately after extubation: rNMB defined as the TOF ratio was <0.9). The secondary outcomes were as follows: (1) the incidence of neostigmine-induced muscle paralysis — the decrease in the TOF ratio after administration of neostigmine. (2) end of surgery - extubation interval — the time from the end of surgery to endotracheal extubation; (3) end of surgery - exit OR interval — the time from the end of the surgery to when the patient was transferred out of the OR; (4) the length of PACU stay; (5) the incidence of hypoxia in the PACU (pulse oxygen saturation <90%); (6) the number of children who required assisted ventilation during the PACU stay — the patients need mask ventilation, larynx mask or endotracheal intubation; (7) neostigmine-related adverse events, such as nausea, vomiting, and bradycardia.According to the previous studies, the incidence of rNMB was 15% in children with routinely using neostigmine to reverse atracurium [ | PMC9824919 |
Discussion | The incidence of rNMB after extubation in pediatric patients with routine use of neostigmine after recovery of spontaneous breathing (experimental group) was not significantly different compared with that in pediatric patients who were provided neostigmine guided by the monitoring of neuromuscular function (control group). Although anesthesiologists were aware of the TOF ratios in the control group, rNMB still occur in 73.3% patients after extubation. A similar result was found in a previous cohort study, in which 64.7% patients had rNMB at tracheal extubation, despite neostigmine administration and qualitative neuromuscular function monitor used [The use of muscle relaxant antagonists at the end of the surgery was reported to be associated with a decreased risk of mortality [This study has some limitations. First, awake pediatric patients are not tolerant of neuromuscular monitoring. Therefore, monitoring of neuromuscular function was not carried out during the PACU stay. Consequently, the incidence of rNMB in the two groups during the PACU stay was unknown. Second, all the pediatric patients in this study were transferred to the PACU after surgery for observation. Therefore, the results of this study do not apply to pediatric patients who need to return to the ward directly after surgery. | PMC9824919 |
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Conclusions | residual neuromuscular block | MINOR | Recovery of spontaneous breathing could be used as a substitute of neuromuscular monitoring to guide neostigmine use in pediatric patients following minor surgeries. However, care should be taken for the residual neuromuscular block. | PMC9824919 |
Acknowledgements | Ellen | We thank Ellen Knapp, PhD, from Liwen Bianji, Edanz Group China ( | PMC9824919 |
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Authors’ contributions | Study design: L Yang, Y Zuo; data collection: Na Hu, H Chang; data analysis: D Yang, L Yang; manuscript preparation: L Yang. The authors read and approved the final manuscript. | PMC9824919 |
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Funding | WEST | This study was supported by Research Grant from the 1.3.5. project for disciplines of excellence. West China Hospital, Sichuan University (ZYGD20005) | PMC9824919 |
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Availability of data and materials | The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. | PMC9824919 |
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Declarations | PMC9824919 |
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Ethics approval and consent to participate | WEST | This study was approved by the Ethics Committee of West China Hospital, Sichuan University (approval number: 2017-349). | PMC9824919 |
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Consent for publication | Not applicable. | PMC9824919 |
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Competing interests | the authors declare that they have no competing interests. | PMC9824919 |
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References | PMC9824919 |
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Background | AVNRT | RECURRENCES | Considering that ablation of atypical AVNRT may be unsuccessful after ablation at the right posterior septum, in this study, we aimed to present an optimal method for ablation of atypical AVNRT. Also, we evaluated the efficacy of this technique for preventing recurrences. | PMC10199465 |
Methods | AVNRT | This is a prospective, double-center study. It was conducted on 62 patients with atypical AVNRT referred for radiofrequency ablation. The patients were randomly divided into two groups before ablation: 1-Group A (n = 30): treated with conventional ablation at the anatomic area of the slow pathway; 2-Group B (n = 32): ablation was done 2 mm higher in the septum during fluoroscopy. | PMC10199465 |
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Results | AVNRT | RECURRENCE | The mean age of patients in groups A and B were 54 ± 11.7 and 55 ± 12.2, respectively (P = 0.43). In group A, ablation was successful in 24 (80%) patients following right-sided slow pathway ablation, and the remaining patients required further treatment with either a left-side approach (N = 4, 13.3%) or ablation of additional regions (N = 2, 6.7%). In group B, ablation was successful in all patients. After a 48-month follow-up, recurrence of symptomatic atypical AVNRT was detected in 4 (13.3%) patients of group A and none of group B patients (p < 0.001). | PMC10199465 |
Conclusion | arrhythmia | RECURRENCE, ARRHYTHMIA | In patients with atypical AVNRT, ablation 2 mm above the conventional area is more promising regarding success rate and recurrence of the arrhythmia. | PMC10199465 |
Keywords | PMC10199465 |
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Introduction | AVNRT, tachycardia | RECURRENCES, AV NODAL REENTRANT TACHYCARDIA, SUPRAVENTRICULAR TACHYCARDIA | AV nodal reentrant tachycardia (AVNRT), the most common type of supraventricular tachycardia, is characterized by tachycardia with a narrow QRS of supraventricular origin, sudden termination, and a heart rate of 150–250 beats/min [Most AVNRT cases can be treated with slow pathway ablation from the right part of the inferoseptal segment [Regarding ablation of atypical AVNRT may be unsuccessful after ablation at the right posterior septum, we hypothesized that patients with atypical AVNRT might have a structural and/or electrophysiological remodeling of the AV nodal tissue, resulting in a superior displacement of slow pathway. Therefore, in this prospective study, we aimed to present an optimal method for ablating atypical AVNRT. Also, we evaluated the efficacy of this technique for preventing recurrences. | PMC10199465 |
Materials and methods | PMC10199465 |
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Study population | AVNRT | RECURRENCE | This research is a prospective, double-center study. It was conducted on 62 patients with atypical AVNRT referred for radiofrequency ablation (2013–2019). All patients with symptomatic AVNRT with at least one episode every two months were included in this study. Those patients who underwent ablation therapy and developed recurrence were excluded. Demographic and clinical data were recorded before ablation. The patients were randomly divided into two groups before ablation based on random digit number: 1-Group A (n = 30): treated with “conventional ablation” at the anatomic area of the slow pathway; 2-Group B (n = 32): ablation was done 2 mm higher in the septum (during fluoroscopy). This study was approved by the Ethics Committee of the Shiraz University of Medical Sciences (IR.SUMS.MED.REC.1396.04), and written informed consent was obtained from the subjects. | PMC10199465 |
Definition of atypical AVNRT | AVNRT, reentrant tachycardia | Atrio-ventricular node reentrant tachycardia (AVNRT) was diagnosed by fulfillment of standard criteria during an electrophysiologic study with atrial/ventricular pacing maneuvers: 1-Typical (slow-fast) AVNRT was characterized by AH/HA ratio > 1, and HA ≤ 70 ms, 2-Atypical AVNRT was defined by delayed retrograde atrial activation with HA > 70 ms. If the AH was < 200 ms and the AH < HA, the atypical AVNRT was diagnosed as fast-slow. If AH > 200 ms and AH > HA, the atypical AVNRT was diagnosed as slow-slow. | PMC10199465 |
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Electrophysiologic study | All of the antiarrhythmic drugs were stopped five lifetimes before the study. Five electro catheters were inserted into the heart, three via the left femoral vein and two via the right femoral vein. Three quadripolar catheters from the left femoral vein were placed in RA-RV-HIS location, and one decapolar catheter from the right femoral vein was placed into the CS. An ablation catheter was inserted into the right atrium to map and ablate the slow pathway. | PMC10199465 |
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Slow pathway ablation | AVNRT, arrhythmia, group-A | JUNCTIONAL RHYTHM, ARRHYTHMIA | The patients were randomly divided into two groups before ablation: 1-Group A (n = 30): treated with “conventional ablation” at the anatomic area of the slow pathway; 2-Group B (n = 32): ablation was done 2 mm higher in the septum (during fluoroscopy):In group-A, conventional anatomic slow pathway RF ablation was performed according to established techniques. In brief, a conventional 4-mm ablation catheter (Boston Scientific Stinger Ablation Catheter, D Curve 7 F) was positioned at the postero-septal (infero-septal) part of the tricuspid annulus until an A-V ratio of < 1 was recorded. The ablation catheter was kept at the ostium of the coronary sinus (CS) as visualized in the left anterior oblique view (mapping was not performed at the mid or anterior septum). When multi-component signals or low-amplitude potentials were obtained, RF current, 30 to 40 W aimed at a temperature of 55–60 °C, was delivered for up to 30 s until a junctional rhythm with 1:1 retrograde V-A conduction was observed. RF delivery was immediately stopped if V-A conduction was not seen. Once junctional rhythm with V-A conduction was recorded, energy delivery was continued for 30 s. Following RF ablation, arrhythmia induction with the use of Isuprel was performed. Successful ablation was defined as RF-induced junctional rhythm (conducted to the atria) and non-inducibility of AVNRT with programmed stimulation during Isuprel infusion.In group B, RF ablation was performed at 2 mm higher in the septum with the same techniques and catheters used for patients in Group-A. | PMC10199465 |
Statistical analysis | Continuous data were expressed as Mean ± SD. The normality of data was analyzed using the Kolmogorov-Smirnoff test. Independent sample t-test and chi-square tests were used for bivariate analysis. P value 0 < 0.05 was considered to be statistically significant. The statistical software IBM SPSS Statistics for Windows version 22.0 (IBM Corp. Released 2013, Armonk, New York) was used for the statistical analysis. | PMC10199465 |
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Results | PMC10199465 |
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Baseline characteristics | GROUP B | A total of 62 patients with atypical AVNRT were studied. Group A (n = 30, 15 male, age 54 ± 11.7 years) were treated with “conventional ablation” at the anatomic area of the slow pathway. Group B (n = 32, 13 male, age 55 ± 12.2 years) were treated with ablation 2 mm higher in the septum. There were no significant differences in age and sex between the two groups (P = 0.51 and P = 0.43, respectively). | PMC10199465 |
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Electrophysiological findings | fast-slow AVNRT, AVNRT, arrhythmia | ARRHYTHMIA | In group A, 26 of the 30 patients (86.6%) had fast-slow AVNRT, and 4 patients (13.3%) had slow-slow AVNRT. In group B, 27 of the 32 patients (84.3%) had fast-slow AVNRT and 5 patients (15.6%) had slow-slow AVNRT. Electrophysiological findings during arrhythmia are shown in Table
Electrophysiological and ablation findings in patients with atypical AVNRTJunctional Rhythm(During Radiofrequency) V-A Block(During Radiofrequency) | PMC10199465 |
Ablation characteristics | Group-A patients were treated with “conventional ablation” at the anatomic area of the slow pathway as described. This was successful in 24 patients (80%). In 4 patients, a left-sided approach was accomplished following unsuccessful right-sided slow pathway ablation. In 2 patients, additional lesions were needed in the roof of the proximal coronary sinus following unsuccessful ablation.Group-B patients were treated with ablation 2 mm higher in the septal area during fluoroscopy. This was successful in all patients without the need for additional lesions at other sites (p = 0.01 for the percentages of successful right-sided slow pathway ablation). The ablation characteristics of the two groups are highlighted in Table | PMC10199465 |
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Patients follow-up | AVNRT, group-A, AV block | RECURRENCES, RECURRENCE, AV BLOCK | 48-month follow-up was completed in groups A and B patients. Recurrence of symptomatic atypical AVNRT was detected in 4 (13.3%) patients of group A and none of the group B patients (p < 0.001 for the percentages of recurrences in group-A versus group B). No case of AV block was noted during follow-up in either group-A or group B patients (Table
Follow-up results of patients | PMC10199465 |
Discussion | AVNRT | In contrast with its typical form, Literature data on atypical AVNRT need to be revised because of its low prevalence. Atypical AVNRT has been identified as a predictor of lower ablation success rates, and the optimal method of catheter ablation still needs to be established. The same anatomic site and nature of the pathways involved in the atypical AVNRT have yet to be recognized, and efforts to provide a reasonable hypothesis based on anatomic or anisotropic models have been made [In contrast to our result, Katritsis et al. studied 2079 patients with AVNRT, of whom 113 were cases of atypical AVNRT or coexistent typical and atypical AVNRT. They found that ablation in the conventional area is the treatment of choice in typical and atypical patients [Our study had some notable strengths, especially 48-month patient follow-up. The limitation of our study was the small sample size. We recommend further studies with more cases of atypical AVNRT. | PMC10199465 |
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Acknowledgements | Not Applicable. | PMC10199465 |
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Author contributions | H.B., A.A. and S.S. convenience the idea for the manuscript. R.F., K.P and M.B. collected data. H.B., A.A. and S.S. and M.R. contributed to data interpretation. H.B. and M.B. and M.R. drafted the manuscript. R.F. and H.B. and M.R. revised and edited the manuscript. H.B. also revised the manuscript critically and stood as a Guarantor of the manuscript. All authors read and approved the final version of the manuscript. All authors confirm that all methods were carried out in accordance with relevant guidelines and regulations. | PMC10199465 |
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Funding | No financial support was received for this study. | PMC10199465 |
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Data Availability | SPSS data of the participants can be requested from the authors. Please write to the corresponding author if you are interested in such data. | PMC10199465 |
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Declarations | PMC10199465 |
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Ethics approval and consent to participate | DISEASE | The privacy of the patients was protected. A detailed explanation of the disease and treatment was provided. This study was approved by the Ethics Committee of the Shiraz University of Medical Sciences (IR.SUMS.MED.REC.1396.04), and written informed consent was obtained from the subjects. All methods were carried out in accordance with relevant guidelines and regulations. | PMC10199465 |
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Consent for publication | Not applicable. | PMC10199465 |
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Competing interests | The authors declare no competing interests. | PMC10199465 |
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References | PMC10199465 |
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Objective | ovarian endometrioma | This study aimed to explore the optimal time of laparoscopic cystectomy for unilateral ovarian endometrioma patients and evaluate the influence on ovarian reserve. | PMC10294415 |
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Materials and methods | endometrioma, ovarian endometrioma | ENDOMETRIOMA | This prospective randomized controlled study included 88 women with unilateral ovarian endometrioma at a tertiary teaching hospital. All patients received their first identified diagnosis of ovarian endometrioma by ultrasound (> 4 cm and ≤ 10 cm) and were administered an oral contraceptive pill (OC) for one cycle before laparoscopy. They were randomly divided into two groups: laparoscopy at the late luteal phase (group LLP) (n = 44) (termination of OC for two days) and laparoscopy at the early follicular phase (group EFP) (n = 44) (day 3 after menstruation). Basic clinical characteristics were recorded. Serum Anti-Müllerian hormone (AMH) levels were measured at various times to predict ovarian reserve. Serum levels of Anti-Müllerian hormone (AMH) were measured at several time sites to predict the ovarian reserve; AMH and leukocyte esterase (LE) levels of the endometrioma wall were measured. | PMC10294415 |
Results | Before surgery, serum AMH levels decreased in both groups from preoperative to one week and six months postoperatively. In contrast, the difference values of group EFP were larger than those of group LLP at postoperative one week and postoperative six months (1.87 ± 0.97 vs. 1.31 ± 0.93, | PMC10294415 |
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Conclusion(s) | ovarian tissue loss, ovarian endometrioma | The optimal time for laparoscopic cystectomy for patients with first identified unilateral ovarian endometrioma is the late luteal phase, which reduces ovarian tissue loss and preserves ovarian reserve effectively and safely. | PMC10294415 |
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Keywords | PMC10294415 |
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Introduction | Endometriosis, endometriosis, chronic pelvic pain, intraoperative blood loss, Ovarian endometriomas, infertility, ovarian endometrioma | ENDOMETRIOSIS, ENDOMETRIOSIS, DYSMENORRHEA, CAVITY, INTRAOPERATIVE BLOOD LOSS | Endometriosis (EMT) is a common gynecological condition characterized by endometrial tissue outside the uterine cavity resulting in dysmenorrhea, chronic pelvic pain, pelvic masses, and infertility, which can seriously affect a woman’s health and quality of life. Ovarian endometriomas are the most common type of EMT, with a prevalence of 17–44% in patients with endometriosis [Anti-Müllerian hormone (AMH) is produced by the granulosa cells of primary, preantral, and small antral follicles, not primordial ones. Therefore, AMH level indirectly represents the quantity of the ovarian follicle pool, estimated by the number of early growing-stage follicles. Moreover, serum AMH levels appear independent of the menstrual cycle and are unaffected by gonadotropin-releasing hormone (GnRH) agonists or oral contraceptives [Currently, no precise data exist on whether laparoscopic endometrial cystectomy with different menstruation phases reduces the damage to ovarian function, shortens the operation time, reduces intraoperative blood loss, and accelerates patient recovery. Therefore, this study aimed to explore the optimal timing of the first laparoscopic cystectomy in ovarian endometrioma patients with unilateral and evaluate the influence on the patient’s ovarian reserve. | PMC10294415 |
Materials and methods | endometriosis, ovarian endometrioma, ovarian, uterine, or tubal surgery history, malignant ovarian diseases, endocrine disease | ENDOMETRIOSIS, INFILTRATED, COMPLICATIONS, ENDOCRINE DISEASE | This prospective clinical study was approved by the board of Fujian provincial hospital ethics committee (2018ky0024) and registered under the clinical trial registry number (ChiCTR1800019766). All patients provided preoperative informed consent after being informed of potential risks and complications. All patients provided preoperative informed consent after being informed of potential risks and complications. In total, 88 patients with unilateral ovarian endometrioma were recruited into this prospective study at the Department of Obstetrics and Gynecology in Fujian provincial hospital from March 2019 to March 2021. After inclusion in the study, all patients were administered an oral contraceptive pill (OC, drospirenone, and ethinylestradiol) for one cycle to determine the timing of surgery. Inclusion criteria were as follows: (1) age 20–36 years; (2) regular menses; (3) clinical and ultrasonographic finding of unilateral ovarian endometrioma ≥ 4 cm and ≤ 10 cm the first time; (4) without pregnancy or plan to get pregnant in six months. Exclusion criteria were as follows: (1) any suspicious finding of malignant ovarian diseases; (2) ovarian, uterine, or tubal surgery history; (3) endocrine disease and treatment history; (4) long-term use of hormonal drugs for more than three months (e.g., gonadotropin-releasing hormone analogs); (5) smokers. Patients with infiltrated endometriosis were excluded from this study based on transvaginal ultrasound and gynecological examination. Patients who fulfilled the inclusion criteria and consented to participate in the study were enrolled. The study objectives and steps were explained to all patients before enrollment. All experimental procedures were performed following the guidelines for the Declaration of Helsinki. Our study was conducted according to the CONSORT guidelines [ | PMC10294415 |
Sample size calculation | Using a two-sided equal-variance t-test, group sample sizes of 30 and 30 achieved 81.328% power to reject the null hypothesis of equal means when the mean population difference was 1.13. The standard deviation for both groups was 1.51, and the significance level (alpha) was 0.05 [ | PMC10294415 |
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Randomization | ovarian endometrioma | All patients were diagnosed with ovarian endometrioma by ultrasound and were administered OC for one cycle before laparoscopy to inhibit ovulation and identify the menstruation phase. After written consent, the randomized number was concealed in an opaque, sealed envelope for each patient, and the envelopes were opened sequentially by a study nurse before surgery. Randomization was performed in a 1:1 ratio, according to a computer-generated number list, into two groups. The single number drawn was included in the group LLP, and the double number was included in the group EFP. All patients were randomly divided into two groups: laparoscopy at late luteal phase (group LLP) (n = 44): termination of OC for two days; and laparoscopy at Early follicular phase (group EFP) (n = 44): day 3 after menstruation. | PMC10294415 |
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Surgical technique | endometriosis | ENDOMETRIOSIS, PNEUMOPERITONEUM | All surgeries were performed by the same surgeons with extensive experience in endometriosis surgery, who were particularly aware of the necessity to avoid damaging or removing healthy ovarian tissue. Surgeons were blinded to the result of group Randomization. Laparoscopic pneumoperitoneum was induced by CO | PMC10294415 |
Hormonal assays | All patients provided serum specimens prior to anesthesia, as well as at one week and six months following the procedure. Venous blood samples were obtained, and serum was extracted by centrifugation. According to manufacturer’s instructions, serum E2 and P levels were measured by enzyme-linked fluorescent assay (ELISA; Beckman Coulter Inc., Ireland). Serum AMH level was measured by a commercially available enzyme-linked immunosorbent assay kit (ELISA; Beckman Coulter Inc., Ireland) and reported as nanograms per milliliter with a detection limit of 0.16 ng/mL. Postoperative serum AMH level and AMH decline were the primary outcome measures. | PMC10294415 |
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Tissue sample collection | After a naked-eye examination of the entire cyst wall, five pieces of the specimen of 5 mm | PMC10294415 |
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Unilateral ovarian involvement | endometrioma | ENDOMETRIOMA | We compared the potential role of unilateral ovarian involvement on preoperative levels and postoperative changes in AMH values after laparoscopic endometrioma excision. AMH decline (% decline AMH) was used to compare the changes in AMH levels in endometrioma resected at different menstrual cycles. The rate of AMH decline was calculated using the following formula: (% decline AMH) = (preoperative AMH level – AMH at one week or six months postoperatively)/preoperative AMH level. | PMC10294415 |
Statistical analysis | Categorical variables are described using proportions. Baseline patient characteristics were calculated via t-test for comparisons of normally distributed data and the rank-sum test for comparisons of non-normally distributed data. Count data were summarized as percentages and compared using chi-square and Fisher’s exact tests. Analysis of variance (ANOVA) was used in intra-group comparison at different time points. A two-sided | PMC10294415 |
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Results | PMC10294415 |
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Baseline characteristics | blood loss, SD, r-AFS, infertility | BLOOD LOSS, DYSMENORRHEA | No significant differences existed in age, cyst size, gravidity, parity, infertility, dysmenorrhea, r-AFS Staging, blood loss volume, and operation time between the two groups. Serum progesterone was significantly higher in the late luteal phase than in the early follicular phase on the day of surgery ([2.46 ± 1.43] vs. [0.43 ± 0.34];
Clinical characteristics of the study subjects***: Data are presented as mean ± SD or n (%). a: Groups compared by t-test; b: Groups compared by Pearson’s chi-squared test or Fisher’s exact test; | PMC10294415 |
Acknowledgements | We are grateful to everyone involved in conducting the study, analyzing the data, and producing the manuscript. | PMC10294415 |
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Author Contributions | Qing Wu and Tan Lin not only conceived and designed the study but also participated in the drafting and writing of the manuscript. They also supervised the study and critically revised the manuscript. Qing Wu, Qingmei Yang, Lin Wu and Yanling Lin collected the clinical data. Qing Wu, Qingmei Yang and Tan Lin were responsible for drafting and writing the manuscript and conducting statistical analyses. All the authors substantially contributed to the revision of the manuscript. | PMC10294415 |
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Funding | This study was supported by the Zhejiang Chinese Traditional Medicine Scientific Research Fund Project (2021ZB025) and Health Science and Technology Program of Zhejiang Province (2023KY054). The funders had no role in the study design, data collection and analysis, publication decision, or manuscript preparation. | PMC10294415 |
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Data Availability | Data from this study are publicly unavailable owing to ethical and legal restrictions. However, data may be made available upon reasonable request to the corresponding author. | PMC10294415 |
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Declarations | PMC10294415 |
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Competing interests | The authors declare no competing interests. | PMC10294415 |
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Ethical approval and consent to participate | Ethical approval (2018ky0024) to conduct the study was provided by the Institutional Ethics Committee of Fujian provincial hospital ethics committee and registered under the clinical trial registry number (ChiCTR1800019766). | PMC10294415 |
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Consent for publication | Not applicable. | PMC10294415 |
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Provenance and peer review | Not commissioned, externally peer-reviewed. | PMC10294415 |
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References | PMC10294415 |
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2. Materials and Methods | PMC10384259 |
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2.1. Participants | coronary artery dysfunction, cerebrovascular and peripheral vascular disorders | OBESE, DIABETES MELLITUS, INSULIN RESISTANCE, BRONCHIAL DISEASE, HYPOTHYROIDISM, HIGH BLOOD PRESSURE | In this 12-week randomized controlled trial, forty-two obese premenopausal women (aged 40 to 50 years) were screened and divided into two groups at random: the intervention group (CAST-CR), who underwent CAST with caloric restriction, or the control group (AT-CR), who received aerobic training in addition to caloric restriction, as shown in Patients were chosen to participate in this study upon meeting the following eligibility criteria: premenopausal women who were obese and reported insulin resistance with a HOMA-IR cutoff value of 1.62 [Subjects with coronary artery dysfunction, diabetes mellitus, cerebrovascular and peripheral vascular disorders, high blood pressure, hypothyroidism, and persistent bronchial disease, as well as those on drugs known to have an effect on physical activity or metabolism or those who were unable to perform the essential testing procedures, were excluded. | PMC10384259 |
2.2. Randomization | To avoid bias, random assignments of the participants were carried out in two phases. First, fellow physiotherapists working in ambulatory clinics identified all women who satisfied the study’s inclusion criteria and did not have a criterion for exclusion. Second, women were assigned randomly in a 1:1 ratio to either the CAST-CR or AT-CR groups following a medical consultation through the launching of an obscure envelope designed by an unbiased subject with random number creation. Patients had given informed legal consent to participate in the study and to generalize the results. This work was officially approved by the Institutional Review Board of the Faculty of Physiotherapy, Cairo University (no. P.T.REC/012/002156), registered in the Clinical Trials database: | PMC10384259 |
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2.3. Evaluative Procedures | PMC10384259 |
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2.3.1. Anthropometric Parameters | At baseline and after 3 months, anthropometric measures were taken while participants wore hospital gowns without shoes. Height was evaluated with a standard scale on a portable stadiometer to the closest 0.1 cm with bare feet, and a standard weight scale was used to measure body weight to the nearest 0.1 kg while the subject was wearing light clothing. At the end of a typical expiration, the waist circumference was assessed utilizing a constant tension tape (inelastic tape), with arms loose along the sides, at the midpoint between the lowest part of the lower rib and the highest point of the hip in the mid-axillary axis. The BMI was calculated by dividing a person’s weight in kilograms by their height in meters squared. | PMC10384259 |
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2.3.2. Abdominal Adiposity | Visceral adipose tissue (VAT) and subcutaneous fat were assessed using magnetic resonance imaging with a 1.5 Tesla magnet (Siemens Magnetom Symphony, Erlangen, Germany). Using a gradient echo “in phase” and “out phase” sequence, a single slice at the L4 level was used to evaluate adipose tissue distribution. The classification system of Shen et al. [ | PMC10384259 |
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2.3.3. Blood Sampling and Analysis | INSULIN RESISTANCE | Venous blood samples were taken from an antecubital vein at approximately 8:00 a.m. by a qualified technician after an overnight fast. Low-density lipoprotein (LDL), total cholesterol, high-density lipoprotein (HDL), triglyceride, hepatic enzymes, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) were measured by a standard kit (CELM, Barueri, Brazil). Concentrations of blood glucose were estimated through a glucose oxidase technique (Glucose-Analyzer II, Beckman Industries, Fullerton, USA). An insulin enzyme-linked immune-sorbent assay kit (ALPCO, Salem, NH, USA) was used to assess plasma insulin levels. Homeostasis model assessment-estimated insulin resistance (HOMA-IR) was utilized to estimate IR. Fasting blood glucose (FBG) and immunoreactive insulin (I) were used to calculate HOMA-IR as follows: (HOMA-IR = fasting insulin (μIU/mL) × fasting glucose (mmol/mL)/22.5.) [ | PMC10384259 |
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2.3.4. One-Repetition Maximum | EVENT | One-repetition maximum (1RM) is the highest amount of load that can be borne while effectively finishing one repetition of an exercise. Initially, the test begins with a warm-up of 6 to 10 repeats with approximately half of the expected load for the primary attempt in the 1RM test. Following two minutes of rest, patients were directed to try to achieve two repetitions. If two repetitions were accomplished in the first experiment, or even if neither was accomplished, a second repetition was undertaken with a workload higher or lower than that given in the previous attempt after a three-to-five-minute recovery period. These approaches were further refined in a third and final attempt in the event that a single repetition maximum was not yet established [ | PMC10384259 |
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2.4. Intervention | PMC10384259 |
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2.4.1. Exercise Training Protocols | Both exercise groups underwent a 12-week supervised training program with a similar amount of training time, working out for 60 min per day, three days per week. Sufficient warming up and cooling down in the form of large muscle stretching, flexibility exercises, breathing exercises, and low-intensity gait (50% of maximum heart rate (max HR)) were attempted for all subjects. Adequate time was given to familiarize patients in the resistive group by enabling them to execute one set of each workout on various weight machines. Similarly, enough time was given to familiarize patients with the treadmill and safety concerns within the aerobic training group. | PMC10384259 |
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2.4.2. Aerobic Exercise Training Protocol | Following a warm-up, on nonconsecutive days, patients in this group achieved walking using a treadmill at a modest speed without inclination three times a week. The intensity of exercise was specified according to the Karvonen equation, while the target heart rate = [(max HR − resting HR) × % intensity] + resting HR, where max HR = 220-age. Patients began training with 60% of max HR and gradually progressed to achieve 75% of max HR by weeks 7 through 12 [ | PMC10384259 |
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2.4.3. Concurrent Exercise Training Protocol | premature fatigue | CAST was executed three times a week over 12 weeks, consisting of 30 min of resistance training and 30 min of aerobic exercise (participants adopted the same previously described aerobic training but just for 30 min). Resistance training was conducted prior to aerobic training to prevent premature fatigue that may result from aerobic exercise [ | PMC10384259 |
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2.4.4. Dietary Intervention | During the baseline period, participants engaged in an individualized nutritional session where the study dietitian provided proper food preparation and selection. Throughout this session, daily energy needs were defined by estimating resting energy expenditure. Subjects were directed to diminish their caloric intake by 500–1000 kcal a day, with the aim of achieving a weight reduction of 10% through a low-calorie diet (LCD). A diet with a daily caloric intake of between 800 and 1200 kcal is referred to as an LCD. The LCD was composed of 30% fat, 15% protein, 55% carbohydrates, and 20–30 g of fiber/day [ | PMC10384259 |
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2.5. Outcome Parameters | SECONDARY, ADIPOSITY | The primary outcome was the change in HOMA-IR. Changes in anthropometric measures, abdominal adiposity, and metabolic parameters were secondary outcomes. Assessments were carried out at the beginning and following 12 weeks of intervention. | PMC10384259 |
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2.6. Blinding | Double blinding was used, where patients and assessors who performed all assessments were unaware of the patients’ treatment group. | PMC10384259 |
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2.7. Statistical Analysis | The normality and homogeneity of variance were checked before performing the final analysis using the Shapiro–Wilk and Levene tests, and no violations were found for any of the dependent variables. The adherence of all participants to the diet program was estimated, where χ | PMC10384259 |
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3. Results | REGRESSION, RECRUITMENT | G*Power (version 3.0.10, Germany) was used to calculate the sample size. With two independent groups, a sample size of 34 patients was considered sufficient based on F tests (MANOVA: effects and interactions) with Type I error = 0.05, power (1-error probability) = 0.80, and effect size = 0.50. To account for the possibility of dropout, 40 patients were recruited (assuming a 15% dropout rate). The progress of participants from recruitment to follow-up is illustrated in The data analysis revealed no significant differences in patients’ demographic and anthropometric characteristics between the two groups prior to intervention (Repeated measures MANOVA revealed a significant main effect of time (Wilks’ Λ = 0.01, F(13, 26) = 186.68, Following the intervention, the two groups had substantial reductions in BMI, WC, total cholesterol, LDL cholesterol, triglycerides, AST, ALT, SFT, VAT, fasting glucose, fasting insulin, and HOMA-IR, as well as an increase in HDL cholesterol (Between-group analyses revealed a significant difference between the two groups, with the CAST-CR group exhibiting the most significant alterations, where the mean differences at a 95% confidence interval were (−3.15, −1.80) for BMI, (−9.13, −5.96) for WC, (−31.28, −25.65) for total cholesterol, (15.32, 8.45) for HDL cholesterol, (−27.58, −18.69) for LDL cholesterol, (−41.62, −36.72) for triglycerides, (−16.50, −12.80) for AST, (−9.65, −7.29) for ALT, (−1.67, −1.07) for SFT, (−2092.59, −1316.25) for VAT, (−0.79, −0.46) for fasting glucose, (−6.43, −5.47) for fasting insulin, and (−1.24, −1.07) for HOMA-IR (Multiple regression analyses revealed that the change in HOMA-IR after treatment was best predicted by BMI (β-coefficient = 0.40, The subjects’ diet adherence in the CAST-CR and AT-CR groups was 90% and 85%, respectively. Diet adherence had no significant relationship with groups ( | PMC10384259 |
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4. Discussion | cardiovascular disease, Weight reduction, abdominal obesity, adiposity, weight loss | OBESE, CARDIOVASCULAR DISEASE, INSULIN RESISTANCE, ADIPOSITY, INSULIN RESISTANCE, REGRESSION, TYPE 2 DIABETES, INSULIN SENSITIVITY | The transition to menopause is associated with adipose tissue storage changes that lead to android body composition, increasing the risk of cardiovascular disease and type 2 diabetes in postmenopausal women [In this study, the effects of CAST with calorie restriction on HOMA-IR, anthropometric measures, abdominal adiposity, and metabolic parameters in obese premenopausal women were compared to those of the control group who received aerobic exercise in addition to caloric restriction. Following 12 weeks of intervention compared to baseline, both groups exhibited a significant enhancement in the selected parameters, with the CAST-CR group showing higher improvement. Between-group differences were noteworthy (The improvement in HOMA-IR observed following exercise and calorie restriction may be attributed to the changes in anthropometric measures, abdominal adiposity, and metabolic markers. In multiple regression analyses, HOMA-IR at baseline and changes in BMI, LDL cholesterol, triglycerides, ALT, VAT, and fasting insulin were the best predictors of HOMA-IR improvement.Exercise in women is related to a remarkable increment in lipolysis of abdominal adipose tissue relative to femoral adipose tissue [Our findings revealed a significant reduction in both visceral adiposity and subcutaneous fat post-intervention, with the CAST-CR exhibiting the most significant changes. These results are consistent with previous reports demonstrating that weight loss using exercise and a low-calorie diet reduces subcutaneous and intra-abdominal fat in obese women [Cross-sectional studies have shown that abdominal obesity is a strong predictor of the development of IR [Abdominal adipose tissue can be regarded as an endocrine organ because of its ability to release adipokines and different substances which are intimately related to IR [It has been proven that AT and dietary interventions are effective strategies for regulating inflammatory processes from visceral elements, including a rise in adiponectin and a decrease in adult inflammatory markers [Weight reduction through lowering fat mass decreases the systemic free-fatty acid content in the bloodstream, consequently diminishing its accessibility to skeletal muscle tissue [Furthermore, expanded utilization of substrates [The effect of aerobic training on insulin resistance has been extensively studied, and it has been found to improve muscle insulin sensitivity by increasing the number of insulin receptors [Furthermore, a resistive exercise involving independent, brief activation of single muscle groups leads to an increase in glucose transporter type 4 (GLUT-4) content and insulin receptors due to muscle mass outgrowth [Additionally, the restoration of insulin sensitivity through aerobic and resistance training might be attributed to the adenosine monophosphate-activated protein kinase (AMPK) pathway [One of the key advantages of our experiment is the use of magnetic resonance imaging (MRI), a precise and widely accepted standard method for determining changes in abdominal adiposity. Additionally, we meticulously examined a number of intermediate parameters that could potentially elucidate the effect of exercise and calorie restriction on insulin resistance (IR). However, it is important to acknowledge the limitations of our trial. We evaluated insulin resistance using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) test, which is widely used in clinical research, but the hyperinsulinemic–euglycemic clamp is considered the gold standard for assessing insulin action. Nevertheless, it is also a more invasive and expensive procedure. Furthermore, we did not investigate the long-term effects of caloric restriction with adequate protein and exercise (CAST) on IR in obese premenopausal women, which would be valuable to investigate in future studies. | PMC10384259 |
5. Conclusions | obesity | OBESITY, OBESE, INSULIN SENSITIVITY, HYPERINSULINEMIA | This trial proposes evidence that significant improvements in insulin sensitivity can be achieved through 12 weeks of CAST with caloric restriction. These results suggest that this exercise regimen may be a superior option for premenopausal women with obesity and hyperinsulinemia. Consequently, such findings may provide an effective non-pharmacological therapy for healthcare professionals to alleviate IR in premenopausal women who are obese and hyperinsulinemic. | PMC10384259 |
Author Contributions | Conceptualization and methodology. Y.M.A., G.E.E.R. and H.F.E.; thorough analysis, Y.M.A., G.E.E.R. and H.F.E.; investigation, Y.M.A., G.E.E.R. and H.F.E.; drafting and article preparation, Y.M.A., G.E.E.R., H.F.E., M.M.T. and M.I.A.; writing—editing and revising, all authors; funding acquisition, M.I.A. The published version of the manuscript has been read and approved by all authors. All authors have read and agreed to the published version of the manuscript. | PMC10384259 |
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Institutional Review Board Statement | This study was carried out in accordance with the Helsinki Declaration and was approved by the Institutional Review Board (or Ethics Committee) of (PTREC/012/002156 on 12/2018). | PMC10384259 |
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Informed Consent Statement | All participants in the research provided their informed consent. | PMC10384259 |
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Data Availability Statement | The corresponding author will provide the identified datasets used in the current study upon reasonable request. | PMC10384259 |
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Conflicts of Interest | The authors declare no conflict of interest. | PMC10384259 |
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Appendix A | Aerobic exercise training protocol. | PMC10384259 |
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Appendix B | Concurrent exercise training protocol. | PMC10384259 |
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References | high-density lipoprotein, ’ | REGRESSION, INSULIN RESISTANCE, ADIPOSITY, INSULIN SENSITIVITY | Study flowchart.Patients’ demographic and anthropometric features at baseline.CAST-CR, concurrent aerobic and strength training with caloric restriction; AT-CR, aerobic training with caloric restriction; BMI, body mass index; SD, standard deviation; level of significance at Anthropometric measures, abdominal adiposity, and metabolic features pre- and post-intervention CAST-CR, concurrent aerobic and strength training with caloric restriction; AT-CR, aerobic training with caloric restriction; BMI, body mass index; HLD, high-density lipoprotein; LDL, low-density lipoprotein; AST, aspartate aminotransferase; ALT, alanine aminotransferase; SFT, subcutaneous fat thickness; VAT, visceral adipose tissue; HOMA-IR, homeostasis model assessment insulin resistance; MD, mean difference; SD, standard deviation; CI, confidence interval; Between-group effects after 3 months of intervention *.CAST-CR, concurrent aerobic and strength training with caloric restriction; AT-CR, aerobic training with caloric restriction; BMI, body mass index; HLD, high-density lipoprotein; LDL, low-density lipoprotein; AST, aspartate aminotransferase; ALT, alanine aminotransferase; SAT, subcutaneous adipose tissue; VAT, visceral adipose tissue; HOMA-IR, homeostasis model assessment insulin resistance; MD, mean difference; CI, confidence interval; *, Data are mean ± SD; Predictors of change in insulin sensitivity by multiple regression analysis.BMI, body mass index; LDL, low-density lipoprotein; ALT, alanine aminotransferase; VAT, visceral adipose tissue; HOMA-IR, homeostasis model assessment insulin resistance; CI, confidence interval; level of significance at Subjects’ adherence to the recommended dietary plan.CAST-CR, concurrent aerobic and strength training with caloric restriction; AT-CR, aerobic training with caloric restriction; % fat, protein, and carbohydrates were calculated based on the total daily energy intake; | PMC10384259 |
1. Introduction | ASD, neuroinflammation, Autism, Autism spectrum disorder, neurodevelopmental disorder, mitochondrial dysfunction, autistic, autism | MITOCHONDRIAL DYSFUNCTION, OXIDATIVE STRESS, PATHOGENESIS, PATHOPHYSIOLOGY | Autism spectrum disorder (ASD) is a pervasive neurodevelopmental disorder with repetitive behaviour which affects interaction and communication. Sulforaphane (SFN), an isothiocyanate abundant in the seeds and sprouts of cruciferous vegetables, has been shown to be effective in alleviating autistic behaviour. We performed a prospective double-blind placebo-controlled study to examine the possible effect of SFN in a paediatric cohort aged three to seven years based on measurements of the Autism Diagnostic Observation Schedule-2 (ADOS-2), the Social Responsiveness Scale-2 (SRS-2), and the Aberrant Behaviour Checklist (ABC). The study consisted of three visits over the duration of 36 weeks (baseline, 18 weeks, and 36 weeks). Twenty-eight of the 40 randomized children completed the study. The mean total raw scores on ABC and SRS-2 improved in both groups, but none of the changes reached statistical significance (ABC: 0 weeks Autism spectrum disorder (ASD) is a pervasive neurodevelopmental disorder affecting the ability to initiate and sustain reciprocal social interaction and communication, as well as being characterized by repetitive behaviour, interests, or activities [Even though the exhaustive pathogenesis description of ASD remains masked, a substantial body of publications has indicated that the pathophysiology of ASD is affected by immune response dysregulation, inflammatory conditions, oxidative stress, and mitochondrial dysfunction [Sulforaphane (SFN, 4-methylsulfinylbutyl isothiocyanate) is an isothiocyanate abundant in the seeds and sprouts of cruciferous vegetables. This multifunctional phytochemical is beneficial for cytoprotection, antioxidant and anti-inflammatory responses, mitochondrial and synaptic function, neuroinflammation, and neuroprotective mechanisms [The hope for the SFN’s efficiency in autism was brought to light by the placebo-controlled double-blind randomized study of Singh et al. [As young children with diagnosed autism are believed to be sensitive to any possible therapeutic intervention, we aimed to examine the possible effect of SFN in the age cohort of three to seven years in the present study by using the objective and subjective criteria for mental and behavioural changes (ADOS-2, SRS-2 and ABC). | PMC9920098 |
2. Patients and Methods | PMC9920098 |
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2.1. Patients and Study Design | DSM-5, autism | SECONDARY, ADVERSE EVENT, SEIZURE DISORDER, COLD, CHRONIC DISEASE | Children aged 3–7 years with a confirmed clinical diagnosis of ASD that was reconfirmed based upon the DSM-5 symptom checklist were enrolled in this double-blind prospective study. Inclusion criteria were an ASD diagnosis, no prior use of sulforaphane-containing supplements, completion of all follow-ups, and a parent/caregiver willing to consent. Exclusion criteria involved proven genetic diagnosis (secondary autism), seizure disorder, chronic disease, and medication affecting testing.The study comprised three visits. The first visit included screening, randomization, and the start of treatment. Two follow-ups were performed at 18 and 36 weeks after the first visit. At each visit, the medical history, physical examination including vital signs, blood samples, adverse event reporting, and SRS-2, ABC, and ADOS-2 scores were obtained. Treatment was discontinued after the 36-week visit. The study was carried out in a randomized, double-blind, placebo-controlled manner. Parents/caregivers were then informed whether their child received sulforaphane or placebo.SFN was administered orally once a day. The subjects were dosed uniformly with 50 µmol SFN per day. Parents/caregivers were instructed to mix the content of one PE/AL bag (1.2 g of the treatment) with a small amount of cold water or other cold food (yogurt, fruit juice). The placebo group received an equivalent dose of spinach puree powder. | PMC9920098 |
2.2. Psychological Examination | autism | To evaluate the severity of ASD symptoms and their changes within the study period, the standardized ADOS-2 assessment was delivered. The ADOS-2 assessments were videotaped and cross-coded by two trained psychologists. All researchers were masked to treatment group assignment. Monitored items were selected from developmentally staged ADOS-2 modules (Module 1—early development nonverbal; Module 1—early words; Module 2—phrase speech; and Module 3—fluent speech). We chose this autism diagnostic symptom measurement instrument because it was possible to rate it in a masked manner. We were able to assess different core symptoms of autism because of its excellent interpersonal objectivity (interrater reliability).Two parent- or caregiver-reported questionnaires (ABC and SRS-2) were collected at each visit. | PMC9920098 |
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