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References | PMC9831378 |
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Background: | ’ | SECONDARY | Fathers are important in establishing healthy behaviors in their children, but are rarely engaged in lifestyle programs. Focusing on physical activity (PA) of both fathers and their children by engaging them together in PA (i.e. “co-PA”) is therefore a promising novel strategy for interventions. The study aim was to investigate the effect of the ‘Run Daddy Run’ on co-PA and PA of fathers and their children, and secondary outcomes such as weight status and sedentary behaviour (SB). | PMC9930712 |
Methods: | SECONDARY | This study is a non-randomized controlled trial (nRCT), including 98 fathers and one of their 6 to 8 years old children (intervention = 35, control = 63). The intervention was implemented over a 14-week period, and consisted of six (inter)active father-child sessions and an online component. Due to COVID-19, only 2/6 sessions could be implemented as planned, the remaining sessions were delivered online. In November 2019-January 2020 pre-test measurements took place, and post-test measurements in June 2020. Additional follow-up test was conducted in November 2020. PA (i.e. LPA, MPA, VPA and volume) of fathers and children were objectively measured using accelerometry, co-PA and the secondary outcomes were questioned using an online questionnaire. | PMC9930712 |
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Results: | ’ | Significant intervention effects were found for co-PA (+ 24 min./day in the intervention compared to the control group, p = 0.002), and MPA of the father (+ 17 min./day, p = 0.035). For children, a significant increase in LPA (+ 35 min./day, p < 0.001) was found. However, an inverse intervention effect was found for their MPA and VPA (-15 min./day, p = 0.005 and − 4 min./day, p = 0.002, respectively). Also decreases in fathers’ and children’s SB were found (-39 min./day, p = 0.022 and − 40 min./day, p = 0.003, respectively), but no changes in weight status, the father-child relationship, and the PA-family health climate (all p > 0.05). | PMC9930712 |
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Conclusion: | The Run Daddy Run intervention was able to improve co-PA, MPA of fathers and LPA of children, and decreasing their SB. Inverse intervention effects were however found for MPA and VPA of children. These results are unique given their magnitude and clinical relevance. Targeting fathers together with their children might be a novel and potential intervention strategy to improve overall physical activity levels, however, further efforts should however be made to target children’s MPA and VPA. Last, replicating these findings in a randomized controlled trial (RCT) is recommended for future research. | PMC9930712 |
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Trial registration number: | This study is registered as a clinical trial (clinicaltrials.gov, ID number: NCT04590755, date: 19/10/2020). | PMC9930712 |
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Keywords: | PMC9930712 |
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Background | ’ | Physical inactivity is a global pandemic and a leading cause of physical and mental health issues [Lifestyle interventions targeting children’s health behaviours, including PA, have often included parents as an important focus of change, as parents play a critical role in the health behaviours of their children [It is highly recommended, when developing and evaluating an effective lifestyle intervention, that a theoretical framework is used, as clear theoretical underpinnings are known to maximize the potential for intervention effectiveness [The primary goal of the present study was to evaluate the efficacy of a newly developed lifestyle intervention for fathers and their children (i.e. ‘Run Daddy Run’ intervention) [ | PMC9930712 |
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Methods | PMC9930712 |
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Study design | The design of the Run Daddy Run study was a non-randomized controlled trial (nRCT), with a two-group pretest-posttest control group. In this design, participants were recruited in sequence (see Fig. Measurements were performed immediately before the intervention (baseline) and immediately after the 14-week intervention (post-test), in June 2020. Five months after the intervention, follow-up measurements were conducted which was one year after the baseline measurements (November 2020). Follow-up measurements were conducted to investigate whether or not intervention effects would be sustained over a longer time period. For the timing of these measurements, see Fig.
Study design and participant flow throughout the trial | PMC9930712 |
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The Run Daddy Run intervention | PMC9930712 |
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Development of the intervention | The Behaviour Change Wheel was used as a theoretical framework to systematically develop the intervention [ | PMC9930712 |
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Content of the intervention | FMS | FMS | The aim of the intervention was to improve father-child co-PA, and consequently the objectively measured PA levels of both. Secondary aims of the intervention were to target (co-) sedentary behaviour (SB), body mass index (BMI), family health climate regarding PA and the quality of father-child relationship. The Behaviour Change Wheel (BCW) was used as a theoretical framework to systematically develop the intervention [In brief, the intervention was implemented over 14 weeks, including two components: (1) a practical component in which six (inter)active sessions were given face-to-face to the fathers and children, of 120 min each, and (2) an eHealth component which was implemented throughout the entire 14-week intervention period (for a timeline, see Fig. For the intervention, participants were randomly assigned to a group, each containing about 12 father-child days. These groups received the same sessions, on a different evening in the same week. The main facilitator was always the same for the three groups, the supporting 2 facilitators were different for the three different groups, minimizing the change of a clustering effect due to participating in the same groups for the entire study duration. The face-to-face sessions took place at the same elementary school in Ghent, East-Flanders (Belgium). Each face-to-face session consisted of a 40-minutes education component and a 60-minute practical component part (see Fig.
Overview of the Run Daddy Run themes across the six sessionsAfter the education component, goals were set by the fathers and children on co-PA. In the subsequent practical component, several exercises were performed with each session focusing on specific fundamental movement skills (FMS) (see Table Second, the eHealth component consisted of a website (
Timeline of the Run Daddy Run intervention under normal circumstances
Timeline of one practical father-child session | PMC9930712 |
The intervention and restrictions during COVID-19 | MAY | During the baseline measurements (November-January 2019–2020), no COVID-19 restrictions were applicable. During the post-test measurements (in June 2020), “mild” COVID-19 restrictions were applicable, meaning that (1) catering industry (e.g. restaurants, bars, cafés) and (non-essential) shops were open, (2) school were open (3) non-contact sports activities and facilities (both indoor and outdoor, amateur and professional) were allowed (4) social contacts were restricted to a maximum of 10 different people per week, and (5) teleworking was recommended but not mandatory. During follow-up measurements (i.e. November 2020),“strict” and strengthened COVID-19 restrictions were applicable [The intervention took place between February and May 2020. Due to COVID-19 restrictions, only 2 of the 6 sessions could be implemented in person as planned, between February and March 2020 (see Fig.
Timeline of the Run Daddy Run intervention under COVID-19 restrictions | PMC9930712 |
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Sample size | The required sample size to evaluate the effect of the intervention was calculated, using the software GPower 3.0.10 [ | PMC9930712 |
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Participants and recruitment | RECRUITMENT | The Run Daddy Run intervention targeted fathers and (one of) their children of the first three years of primary school (i.e. 6–8 years old). For more information on recruitment, see [Father-child dyads were recruited through convenience and snowball sampling, in November 2019-January 2020 (see also [ | PMC9930712 |
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Co-physical activity | Co-PA includes all types of PA that involves “active play”, and is jointly performed by the father and the child (e.g. playing soccer together, rough-and-tumble play, cycling). Co-PA was measured using a 7-day recall diary, investigating all physical activities fathers and children performed together in the last seven days [Based on this, data were retrieved for co-PA, which consisted of co-PA performed 1 on 1 (father with the participating child) and co-PA conducted with additional family members. Total co-PA was then calculated as the sum of co-PA conducted 1 on 1 + co-PA conducted with additional family members. Furthermore, co-PA was also calculated separately for standard weekdays (which cover all weekdays except Wednesdays), Wednesdays (calculated as a separate variable because it is only a half-day school for the children) and weekend days. All co-PA variables were (calculated and) expressed in average minutes/day. | PMC9930712 |
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Physical activity and sedentary Behaviour | PMC9930712 |
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Data collection | Device-based | Device-based measures of PA and SB data were collected using wrist-worn accelerometers (Axivity AX3, 3-axial) (continuous wave-form data, sampling frequency 100-Hz). Compared to hip-worn accelerometers, wrist-worn accelerometers have better wear time adherence and acceptability [ | PMC9930712 |
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Data processing | Minus | Based on the accelerometer data, participants’ total volume of PA (mean Euclidean Norm Minus One (ENMO, in m | PMC9930712 |
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Secondary outcomes: body mass index, PA family health climate and quality of the father-child relationship | Fathers’ Body Mass Index (BMI, in kg/m²) was calculated based on self-reported height and weight through the online questionnaire. BMI z-scores (i.e. a sex- and age adjusted measure of BMI) of children were also calculated based on their weight and height, which were proxy-reported by the father in the questionnaire. The family context on PA (i.e. shared perception and cognitions regarding daily activity behaviours among the family and family members) was surveyed using the validated FHC-PA (i.e. the Family Health Climate Scale for Physical Activity) [ | PMC9930712 |
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Results | PMC9930712 |
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Descriptive statistics | In total, data of 98 father-child dyads were analyzed at baseline (mean age fathers/male caregivers: 43.79 ± 5.92 years, mean age primary school aged children: 8.19 ± 0.99 years; 50.90% boys). The flow diagram of participants throughout the study can be found in Fig. | PMC9930712 |
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Primary outcomes | PMC9930712 |
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Co-physical activity | Results for the self-reported co-PA outcomes are shown in Table | PMC9930712 |
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Physical activity | For PA of the father, relative to the control group, the intervention group significantly improved from pre- to post-test for total volume of PA (+ 6.1 m | PMC9930712 |
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Secondary outcomes: sedentary behaviour, body mass index, PA family health climate and quality of the father-child relationship | SECONDARY | Results for the secondary outcomes are shown in Table | PMC9930712 |
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Discussion | ’ | SECONDARY | This study evaluated the effects of a theory-based, co-created intervention aiming to improve co-physical activity (i.e. the father and the child being active together), which was used as a strategy to increase PA in both children and fathers. The ‘Run Daddy Run’ intervention led to an increase in self-reported father-child co-PA, and in objectively measured MPA and total volume PA of the father, and LPA of the child. However, inverse intervention effects were found for MPA and VPA of the child.Specifically for co-PA, significant intervention effects were found for co-PA conducted For objectively measured PA, significant intervention effects were found in the present study for objectively measured MPA of the father (+ 17 min./day in the intervention vs. control group) and total volume PA of the father (+ 6 mFor objectively measured PA in children, an increase in LPA was found in the present study (+ 35 min./day in the intervention vs. control group), but inverse intervention effects were found for MPA and VPA of the child (-15 min./day and − 4 min./day, respectively). A possible explanation for the fact that in the present study only an effect was found for MPA of father and for LPA of children (and a reversed effect for MPA and VPA), could be due to the fact that the (co-)PA promoted in the intervention did not specifically target high-intensity PA for children and adults. In this way, it is possible that children had to lower the intensity level of their PA by being physically active with their father. Although both fathers and children were offered activities of different intensities and difficulty levels during the intervention (i.e. exercises with increasing difficulty and intensity), the fathers but especially the children should be motivated to achieve an optimal intensity level (i.e. MVPA) while performing (co-)PA, and especially outside the intervention context. In this way, their activities performed could achieve a moderate to intense intensity. Nonetheless, multiple studies have shown that any form of exercise (PA), including LPA and MPA, already has positive effects on health, both in adults and in children [Regarding the secondary outcomes, significant decreases in fathers’ and children’s objectively measured SB were found, which is again comparable to the results of the Australian HDHK/DADEE programs [Last, the intervention did not significantly change the weight status of fathers and children. These findings are in line with the Australian DADEE study, which also did not find an effect on BMI (of both fathers and children) at follow-up [Last, also no significant changes were observed for the father-child relationship and the family health climate regarding PA (all p > 0.05). This could possibly be due to the fact that because of COVID-19 restrictions, not all sessions were implemented as planned. More specifically, only two out of six sessions could be implemented face-to-face as planned, the remaining sessions were delivered online for the fathers and children (i.e. four active face-to-face sessions of about 30 min), replacing the remaining face-to-face sessions as much as possible. In between two sessions, videos with exercise challenges were sent to fathers to keep them motivated. After each session, game materials were sent by postal mail together with a manual and tips on how to use them creatively for exercising together. To replace the education part of the sessions, fact sheets were developed and sent by postal mail, covering some of the remaining themes and/or summarizing the most important themes already provided. However, it is possible that the fathers did not read these fact sheets which consequently can explain why no significant changes were observed for the father-child relationship and the family health climate.Taken together, positive intervention effects of the Run Daddy Run intervention were still found with a total face-to-face contact time of 360 min (instead of the originally planned 720 min). Besides the positive effects, the online alternatives were also positively perceived by the participants. More specifically, in the process evaluation questionnaire, participants of the Run Daddy Run intervention indicated that the researchers provided useful and stimulating alternatives for the intervention during COVID-19. Based on these findings, we might assume that a limited amount of face-to-face contact, in combination with an online component throughout the entire intervention period, may be sufficient to induce and motivate fathers and children towards behavior change. This is an interesting finding, as eHealth interventions have indeed emerged as promising and effective for improving physical activity, mainly because of their ability to provide efficient, interactive and tailored information and content to the user [Strengths of the present study include the theory-based approach which was combined with co-creation, taking into account the needs and the preferences of fathers who are difficult to engage in these kind of programs; the high program attendance and low drop-out and strong retention rates, supporting the acceptability of this study; the use of objective PA data where cut-offs from the same authors (i.e. Hildebrand et al. [Future studies could adapt the (co-PA) activities so that they target and optimally stimulate MVPA in both children and adults. Efforts should also be made to stimulate (co-)PA on days on which father and children have less time and are busier, for example on weekdays. Furthermore, it could be examined whether this intervention is also suitable for a diverse range of families. For example, it could be explored whether this intervention is also suitable for an overweight/obese population, and/or lower educated or ethnic minority groups. If not, new co-creation sessions can be organized so that appropriate and required adaptations can be made. Last, future research is needed to confirm the scalability and practical feasibility of the program in a community trial. However, this programme has currently been adopted by Families Sports Flanders in which the intervention will be implemented on a larger scale in East-Flanders (Belgium), where its effects can be evaluated in a community setting too. | PMC9930712 |
Acknowledgements | Not applicable. | PMC9930712 |
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Author contributions | JL and GC designed the project. RB conducted the accelerometer data processing. JL conducted the data analysis, under the supervision of RB. PJM provided additional input for the study design. JL wrote the original draft. GC, PJM, RB and SC edited the manuscript and provided feedback. All authors read and approved the final manuscript. | PMC9930712 |
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Funding | The research of authors Julie Latomme and Ruben Brondeel is funded by Research Foundation Flanders. The funding body is not involved in the study design, collection, management, analysis and interpretation of data or in writing of the report. | PMC9930712 |
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Data Availability | The datasets used and analyzed during the current study, and the full trial protocol, are available from the corresponding author on reasonable request. | PMC9930712 |
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Ethics approval and consent to participate | This study was approved by the Committee of Medical Ethics of the Ghent University Hospital (Belgian registration number: B670201941599) and registered as a clinical trial on 19/10/2020 (Clinicaltrials.gov NCT04590755). Participants of this study received an information letter in which they were informed on the study, the objectives design of the study, its purpose, confidentiality of data, and the fact that one had the right to leave the study at any time without stating any reason. Informed consents were obtained for all subjects, i.e. fathers signed the informed consent for themselves and for their children (which were aged below 16). Participants’ privacy was ensured, and personal information was coded and password protected. Data were stored on a password-protected computer and central disk space. Data from the website was stored on password-encrypted servers. Only researchers that were part of the research team have access to the data. All methods used in the present study were carried out in accordance with relevant guidelines and regulations. | PMC9930712 |
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Consent for publication | Not applicable. | PMC9930712 |
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Competing interests | The authors declare that they have no competing interests. | PMC9930712 |
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Abbreviations | Minus | Physical activity.Light physical activity.Moderate physical activity.Vigorous physical activity.Moderate-to-vigorous physical activity.Sedentary behaviour.milli-gravitational unit.Euclidean Norm Minus One.Co-physical activity.Fundamental Movement Skills. | PMC9930712 |
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References | PMC9930712 |
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Introduction | cancer | CANCER | Open access funding provided by SCELC, Statewide California Electronic Library ConsortiumSince the beginning of the COVID-19 pandemic, the use of remote telemonitoring and telehealth platforms has been of steadily increasing interest, and implementation continues to rise [One population that has been identified as potentially deriving significant benefit from remote telemonitoring is patients with cancer [Thus, the primary aim of this prospective randomized trial is to assess the feasibility and acceptability of perioperative telemonitoring in patients undergoing complex gastrointestinal oncologic surgery. Herein we present preliminary data regarding patient adherence and satisfaction. | PMC10694107 |
Materials and methods | PMC10694107 |
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Patients | gastrointestinal oncologic surgery | Patients undergoing gastrointestinal oncologic surgery (all colorectal surgery, pancreatectomy, hepatectomy and gastrectomy) at a single institution over 18 years of age who could read and write in English were eligible for inclusion. All eligible patients were screened. Only those patients who had completed all participation by August 31, 2022, were included in the present analysis. All individual patients included in the study provided written informed consent. The study protocol was approved by the institutional review board and was performed in accordance with the ethical standards as laid down by the Declaration of Helsinki. | PMC10694107 |
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Randomization and procedures | A study algorithm detailing randomization, subsequent allocation, and follow-up is shown in the CONSORT diagram in Fig. CONSORT diagramSatisfaction tool | PMC10694107 |
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Outcomes | The primary outcome was feasibility as defined by the percent of patients completing electronic surveys at 70% of all time points. Acceptability was assessed by a patient satisfaction tool assessing ease of use, time burden of participation, and technological access after completion of the 30-day tracking period (Fig. | PMC10694107 |
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Statistical analysis | Univariate analysis was performed using SPSS version 28.0 (Armonk, New York). Patient characteristics including demographics and surgical treatment were compared between groups using Student’s t-test for continuous variables, the Pearson Chi-square test for categorical variables, and the Mann–Whitney U test for ordinal variables. The level of significance was set at | PMC10694107 |
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Results | One hundred and six patients were screened, of which 83 (78.3%) consented to participate and 65 (78.3%) completed participation by August 31, 2022 (Fig. Patient demographicsPerioperative characteristicsLaparoscopic orMIS/robotic assisted Overall, 88% (57 patients) completed 70% of the time points. Patients in the intervention arm were significantly more likely to complete 70% of time points than the control arm (97% vs 79%, Of all 65 patients completing participation across both study arms, 54 completed the satisfaction tool (83.1%). Forty-three of those responding (80%) reported that telemonitoring was helpful to track their daily activities, and 51 (94%) stated that the timing of surveys was “just right.” The majority of patients (47 patients, 87%) did not feel that the survey questions were difficult to understand. Of note, all patients who consented to participate in this study had access to applicable technology at baseline, with 100% of responding patients reporting that they had access to a smart phone. Patient responses regarding access to technology are shown in Fig. Percentage of responding patients with ability to access technology: a comparison between control and intervention groups | PMC10694107 |
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Discussion | PGHD, gastrointestinal oncologic operations | COMPLICATIONS | This study is one of the first to incorporate PGHD in the form of vital signs, mobility, and ePROs, coupled with nursing intervention triggered by set thresholds [However, there are many questions to be answered regarding the applicability and utility of such an approach in the perioperative care of such patients. The patients who consented to participate in this study had a high level of baseline digital literacy, with 100% of participants indicating ownership of or access to a smartphone and the majority indicating that they had access to smartphone apps, internet, and text messaging. It remains unclear whether patients who did not have access to such technology at baseline would be comfortable consenting to a remote telemonitoring program such as the one offered here, as disparities in digital literacy have been associated with inability to participate in internet based health interventions [This study is limited by several factors. Firstly, it was conducted at a single institution, which may limit its generalizability to the general population undergoing complex gastrointestinal oncologic operations, particularly given the young age and the high level of education achieved by this study’s participants. Furthermore, only those patients able to read and write in English were able to be included due to limitations of the technology used. Future studies will need to investigate the use of remote telemonitoring platforms for non-English speakers and those with limited literacy, as this may represent a source of disparity [In conclusion, remote telemonitoring after discharge for patients undergoing complex gastrointestinal oncologic surgery appears feasible and acceptable, and higher levels of adherence are associated with the receipt of nursing triage outreach. Further research will be necessary to understand implications for the duration of telemonitoring, the impact on resource utilization and the potential to mitigate severity of complications by earlier identification. | PMC10694107 |
Funding | Open access funding provided by SCELC, Statewide California Electronic Library Consortium. This study was funded by NIH grant, sponsor ID NR019866-01. | PMC10694107 |
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Declarations | PMC10694107 |
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Conflict of interest | The authors declare they have no conflict of interest to disclose. | PMC10694107 |
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Ethical approval | Informed consent was obtained from all individual patients included in the study. This study was approved by the institutional review board and was performed in accordance with the ethical standards as laid down by the Declaration of Helsinki. | PMC10694107 |
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References | PMC10694107 |
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Abstract | PMC10013951 |
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Introduction | knee arthroplasty, TKA, pain | We aimed to evaluate the efficacy of electroacupuncture in relieving acute pain after total knee arthroplasty (TKA) and related mechanism. | PMC10013951 |
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Methods | electroacupuncture, postoperative acute pain, sham‐acupuncture | In this randomized, single‐blind, and sham‐acupuncture controlled study. Forty patients with postoperative acute pain were recruited and randomly divided electroacupuncture group ( | PMC10013951 |
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Results | calcarine fissure, acute pain, TKA | CORTEX | Compared with the HCs, patients with acute pain following TKA had significantly decreased ALFF value in right middle frontal gyrus, right supplementary motor area, bilateral precuneus, right calcarine fissure and surrounding cortex, and left triangular part of inferior frontal gyrus (false discovery rate corrected | PMC10013951 |
Conclusions | acute pain, pain | The functional activities of related brain regions decreased in patients with acute pain after TKA. The enhancement of the functional activity of precuneus may be the neurobiological mechanism of electroacupuncture in treating pain following TKA.
Bingxin Kang, Chi Zhao, and Jie Ma contributed equally. | PMC10013951 |
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INTRODUCTION | postoperative pain, human diseases, acute postoperative pain, acute pain, Tu, knee osteoarthritis, pain, knee arthroplasty, KOA, TKA, migraine | DISORDERS, CHRONIC PAIN, MIGRAINE, KNEE OSTEOARTHRITIS | Total knee arthroplasty (TKA) can effectively treat end‐stage knee osteoarthritis (KOA) by reducing pain and helping patients to resume daily life activities. Acute postoperative pain after TKA prolongs rehabilitation duration, weakens the therapeutic effect, and thereby decreases the patient's quality of life. Intense postoperative pain is associated with chronic pain, and it may also prolong rehabilitation duration, weaken the therapeutic effect of TKA, and thereby decrease the patient's quality of life (Coppes et al., Acupuncture, a methodology of treating human diseases in China with a history of more than 3000 years, has been applied to various pain disorders, such as migraine (Tu et al., Resting‐state functional magnetic resonance imaging (rs‐fMRI), which gauges fluctuations in the blood oxygen level‐dependent signal, is widely used to explore the neural mechanisms, assess the efficacy of acupuncture treatment, and it is also commonly used for pain research. The amplitude of low‐frequency fluctuation (ALFF), which depicts the intensity of regional spontaneous neuronal activities, strikes a good balance between test‐retest reliability and replicability (Chen et al., In this study, we used rs‐fMRI to explore the brain central mechanism of EA in treating acute pain following TKA. To our knowledge, few neuroimaging research has focused on this area. We speculated that (1) the ALFF patterns in patients with acute postoperative pain might be abnormal, and (2) EA could treat acute pain after TKA by regulating the functional activities of specific brain regions. | PMC10013951 |
MATERIALS AND METHODS | PMC10013951 |
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Standard protocol approvals, registration, and consents | The study took place at Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine from November 1, 2020 to October 31, 2021. The study protocol was preregistered with ClinicalTrials.gov (No.ChiCRT2000033778, June 14, 2020, | PMC10013951 |
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Study participants | loss of consciousness, neurological and psychiatric disorders, pain, KOA, claustrophobia, head trauma, NRS | HYPERPYREXIA, ORGANIC DISEASE, DISEASES | Enrolled were KOA patients having undergone primary unilateral TKA. The inclusion criteria included (1) aged 60–80 years; (2) right‐handed; (3) a pain intensity score of 5 or higher on a 0–10 Numerical Rating Scale (NRS); (4) a score > 24 on the Minimum Mental State Examination. The excluded criteria included (1) a history of neurological and psychiatric disorders, or head trauma with loss of consciousness; (2) serious renal, cardiovascular, respiratory or other organic diseases; (3) any contraindications to rs‐fMRI scanning (such as defibrillator, cardiac pacemaker, metal stents or electronic implant, intraocular mental foreign body, claustrophobia, and hyperpyrexia); (4) unwillingness to sign the consent form; (5) having received acupuncture/EA in the past three months.The sex‐ and age‐matched healthy controls (HCs) without any illness‐induced pain sensation or psychological diseases were also recruited. | PMC10013951 |
Experimental design and sample size | postoperative pain, NRS, sham‐acupuncture, pain | A participant‐blinded, randomized and sham‐acupuncture (SA) controlled clinical trial was applied. Previous studies have shown that 15 participants should be included in each group to ensure stable statistical effect for brain fMRI analysis (Qiu et al., The study lasted for 5 days: from postoperative day (POD) 3 to POD 7. Patients were instructed to completed postoperative pain diary by documenting the onset time, pain intensity (measure by NRS score), rescue medication use, and rs‐fMRI scanning, which collected at POD 3 and POD 7. | PMC10013951 |
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Masking and intervention | The group allocation information was sealed an envelope and given to the acupuncturist. The surgeons, principal investigators, study staff, data analysts, and the participants were blinded to grouping. Using the sham electroacupuncture design in the previous literature(Liu et al., In SA group, noninserted sham needles were applied to the same acupoints as in EA group. The electrodes were attached to these needles with, the same treatment setting as in the EA group. The EA device was turned on, but the electrodes were not inserted into an active port on the device, and no skin penetration or needle manipulation was achieved for “De qi.” Intervention was not performed on HCs. All the patients included in the final analysis completed 5 treatment sessions during the 5‐day treatment. | PMC10013951 |
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Clinical assessment | depression, Depression, NRS, pain | SECONDARY | Nonsteroidal anti‐inflammatory drug was used for analgesia, and supplementary dosage could be administered if needed. No additional analgesic medication was asked for in both EA and SA groups throughout the study. All patients underwent rs‐fMRI scan twice. The demographic information and clinical scale data (dependent variables) at POD 3 (preintervention) and POD 7 (postintervention) were analyzed. The primary outcome was mean reduction in pain intensity represented by the NRS score of patients. To obtain the NRS score, the patients were asked to circle a number ranging from 0 (no pain) to 10 (the most intense pain imaginable) that best fit their current level of pain. The reduction in Zung Self‐Rating Depression Scale (SDS) score was calculated as the secondary outcome. SDS was used to evaluate the subjectively reported depression by the patients. The scale consisted of 20 items and each item was divided into 4 levels according the frequency of symptoms, which is suitable for adults with depression. For the SDS score, patients scored on the scale according to their emotional state. | PMC10013951 |
Rs‐fMRI data acquisition | The rs‐fMRI data were acquired using a Clinical 1.5 Tesla whole body MR imager (United Imaging, Shanghai, China). Although our previous clinical trial (Kang et al., | PMC10013951 |
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Data processing and analyzing | PMC10013951 |
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Statistical analysis | Clinical outcomes were analyzed using a statistical package for windows version 25 (SPSS, IBM Inc., Chicago, IL). A single‐factor ANOVA/two‐sample | PMC10013951 |
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ALFF analysis | The data was processed by the Data Processing Assistant for rs‐fMRI (Restplus) based on Statistical Parametric Mapping 12 (SPM 12, The blood oxygen level‐dependent time series for each voxel was converted to the frequency domain with fast Fourier transform. The square root of the power spectrum was computed and averaged across the specified frequency range (0.01–0.08 Hz) at each voxel. The averaged square root was used as the ALFF, which was transformed by Fisher's To investigate the alternations in HCs and patients in POD 3, we used false discovery rates (FDR) correction for multiple comparison (voxel‐ | PMC10013951 |
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Correlation analysis | The EA‐stimulation difference (EA_ POD 7 vs. POD 3) and group difference (HCs vs. patients at POD 3) were chosen as the regions of interest (ROI). The mean values in the ROI between the two groups were analyzed using the receiver operating characteristic curves. Pearson's correlation coefficients were calculated to indicate the relationship between the mean ALFF values in ROI in patients, where | PMC10013951 |
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RESULTS | PMC10013951 |
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Baseline characteristics | Totally, 38 patients (20 in EA group, 18 in SA group) completed the two rs‐fMRI scans (baseline and after 5‐day treatment). Forty HCs completed one rs‐fMRI scan. Due to excessive head movement (>3 mm) in scan, 7 patients and 8 HCs were excluded (Figure Folw chart of screening, randomization and intervention. SA, sham‐acupuncture; EA, electroacupuncture; rs‐fMRI, resting‐state functional magnetic resonance imaging.Demographic and clinical characteristicsResults are presented as mean (SD).EA, electroacupuncture; SA, sham‐acupuncture; HCs, healthy controls; M, meal; F, female; BMI, body mass index. | PMC10013951 |
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Clinical outcomes | Depression | Table Clinical outcome measurements in the EA and SA groupsEA, electroacupuncture; SA, sham‐acupuncture; NRS, numerical rating scale; SDS, Self‐Rating Depression Scale. | PMC10013951 |
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ALFF analysis | calcarine fissure | CORTEX | Compared with HCs, all patients at POD 3 had significantly lower ALFF in the right middle frontal gyrus (MFG), right supplementary motor area (SMA), bilateral precuneus, right calcarine fissure and surrounding cortex (CAL), and left triangular part of inferior frontal gyrus (IFGtriang) (Table Comparisons of ALFF values between patients at POD 3 and HCsCoordinates (ALFF, amplitude of low‐frequency fluctuation; MNI, Montreal Neurological Institute; POD3, postoperative day 3; HCs, healthy controls; L, left; R, right.Comparisons of ALFF between patients in postoperative day 3 and healthy controls. Blue represents the area with decreased ALFF value. ALFF, amplitude of low‐frequency fluctuation; FMG, middle frontal gyrus; IFGtriang, triangular part of inferior frontal gyrus; SMA, supplementary motor area; PCUN, precuneus; CLA, calcarine fissure and surrounding cortex; L, left; R, right.In EA group, the patients showed significantly higher ALFF at POD 7 in bilateral precuneus, right cuneus, right angular gyrus, bilateral middle occipital gyrus (MOG), and left middle temporal gyrus (MTG), compared with those at POD 3 (Table Comparison of the ALFF between POD 7 and POD 3 in EA groupCoordinates (ALFF, amplitude of low‐frequency fluctuation; MNI, Montreal Neurological Institute; POD3, postoperative day 3; POD7, postoperative day 7; L, left; R, right.Comparisons of ALFF before and after treatment in electroacupuncture group. Red represents the area with increased ALFF value. ALFF, amplitude of low‐frequency fluctuation; PCUN, precuneus; ANG, angular gyrus; MTG, left middle temporal gyrus; MOG, middle occipital gyrus; CUN, cuneus; L, left; R, right. | PMC10013951 |
Correlation between ALFF and pain intensity after intervention | Depression, NRS | The EA‐stimulation difference (EA_ POD 7 vs. POD 3) and group difference (HCs vs. patients at POD 3) as shown by ALFF overlapped in bilateral precuneus, which was chosen as the ROI. Correlation analysis revealed that the change (POD 7–POD 3) in ALFF of bilateral precuneus were negatively correlated with the change of NRS scores (Correlation between the change of ALFF in precuneus with the change of NRS scores and SDS in patients. The change (POD7–POD3) of ALFF in precuneus was negatively correlated with the change of NRS scores and not significantly correlated with the change of SDS in EA group. There was no significant difference between the changed ALFF values of precuneus with the changed NRS scores and SDS. ALFF, amplitude of low‐frequency fluctuation; PCUN, precuneus; NRS, numerical rating scale; SDS, Self‐Rating Depression Scale. | PMC10013951 |
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Complications and adverse events | liver or kidney injury, infection, hematoma, skin ulcer | ADVERSE EVENTS, INFECTION, HEMATOMA, SKIN ULCER | All incisions were healed by the first intention. No skin ulcer, hematoma, infection, liver or kidney injury, or other adverse events was observed. | PMC10013951 |
DISCUSSION | head movements, pain, TKA, depression, Morton et, EA reduced | CORTEX | The transmission of pain in the central nervous system is highly complicated and involves multiple brain regions (Kim et al., We found that patients had lower ALFF in right MFG, right SMA, bilateral precuneus, right CAL, and left IFGtriang following TKA (preintervention), compared with HCs without any pain symptoms. MFG and IFGtriang in the prefrontal cortex can modulate pain perception (Morton et al., This preliminary clinical trial has shown that EA reduced pain intensity and depression tendency after TKA. The analgesia effect of EA may be achieved through regulating the plasticity of brain functional activities, while SA cannot, exert such an effect. And this explains why the patients in EA group had higher ALFF in right cuneus, right angular gyrus, bilateral MOG, right MTG, and bilateral precuneus at POD 7 than at POD 3.The cuneus integrates somatosensory input with other sensory stimuli and cognitive processes, involving the emotion dimension of pain (Price, The EA‐stimulation (EA_POD 7 vs. POD 3) and group (HC vs. POD 3) difference as shown by ALFF overlapped in precuneus. The nucleus cuneiformist is an inhibitory region in the descending pathway, and the hypoactivity in this region indicates reduced inhibition of the pain response in patients, which produces a higher pain score (Schwedt et al., The pain intensity of patients in the SA group was also gradually eased over time after TKA. This may be attributed to the fact, the patients tended to limit their limb movement on the operative side to reduce the pain sensation due to the poor analgesic effect of SA. No changes (POD 7 vs. POD 3) in brain regions related to pain regulation were found on rs‐fMRI in SA group. The different changes of brain regions in the two groups indicated the central mechanisms of EA and SA were different. Part of the therapeutic effect of SA may be produced by the physiological effects on the skin during the stimulation. It should be noted that the AlphaSim correction was applied to explore the mechanism of EA analgesia in our study. Although the precuneus functional activities in EA group were closer to those HCs, the finding did not survive the more stringent FDR correction methods, and the AlphaSim correction method is relatively loose; therefore, further studies are needed.Taken together, we propose that EA relieves acute pain after TKA by increasing right cuneus, right angular gyrus, bilateral MOG, left MTG, and precuneus functional activity. The increased ALFF in pain‐related brain regions may exert beneficial impacts on pain‐regulating functions in patients after TKA. Besides, the EA‐stimulation and group difference overlapped in precuneus, suggesting that precuneus functional activities increase with the decreased pain intensity, which is pivotal to pain processing and regulation. Our research confirms the abnormal decrease of the precuneus functional activity can be reversed by EA, but the results need further validation.Our study has several limitations. (1) The small sample size of the study may increase the likelihood of a false positive error. Ours are preliminary findings, which lack prior power calculations, and thus should to be verified by studies with larger sample sizes. (2) This study only verifies the EA effect at the group level, and the specificity of EA analgesia is not fully explained. Future studies are needed to confirm the immediate effect of EA and validate our findings. (3) Due to excessive head movements, quite a few participants were excluded; but it should be emphasized that the exclusion of the images exerts no impact on treatment response. (4) Due to some practical difficulties and the limitations of experimental conditions, we failed to enroll an untreated group to investigate the effect of elapsed time on pain management after TKA. Hopefully, we will overcome the disadvantages in the subsequent work. | PMC10013951 |
CONCLUSION | acute pain, TKA, pain | In conclusion, the functional activities in the right MFG, right SMA, bilateral precuneus, right CAL, and left IFGtriang in patients with acute pain after TKA decreased. EA on four acupoints (Futu, Zusanli, Yinglingquan, and Yanglingquan) can increase the functional activities of right cuneus, right angular gyrus, MOG, left MTG, and precuneus. The functional activity of the precuneus is a biomarker of pain after TKA. Enhancement of functional activity of precuneus may be the neurobiological mechanism of EA in treating acute pain following TKA. | PMC10013951 |
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AUTHOR CONTRIBUTIONS | LBX | BXK, CZ, and JM conceived the study; BXK drafted the study; HQW, XLG, HX, SZ, CXG, and XRX recruited the participants. XYA and JX collected clinical data. MMD and CZ were responsible for statistical analyses and tables. LBX and JS have primary responsibility for the final content. All authors contributed to writing and revising the paper and agreed to submission. | PMC10013951 |
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CONFLICT OF INTEREST STATEMENT | The authors declare that they have no conflict of interest. | PMC10013951 |
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ETHICS STATEMENT | This study was approved by the Ethics Committee of Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine and was in accordance with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Written informed consent to participate was obtained from all of the individual participants included in the study. | PMC10013951 |
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TRIAL REGISTRATION | The trial was registered in Chinese Clinical Trial Registry (ChiCTR2000033778). | PMC10013951 |
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PEER REVIEW | The peer review history for this article is available at | PMC10013951 |
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ACKNOWLEDGMENTS | We are grateful to the participants who volunteered to participate in this research. | PMC10013951 |
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DATA AVAILABILITY STATEMENT | The data sets used and analyzed during the current study are available from the corresponding author on reasonable request. | PMC10013951 |
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REFERENCES | PMC10013951 |
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Background | Ciprofol is a novel 2, 6-disubstituted phenolic derivative anesthetic that binds to the gamma-aminobutyric acid-A receptor. | PMC10147789 |
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Aim | To determine the equally potent dose of ciprofol compared with propofol as an induction agent for general anesthesia in patients undergoing selective surgery, and to assess its safety. | PMC10147789 |
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Method | ADVERSE EVENTS, SECONDARY | A total of 109 patients undergoing selective non-emergency, non-cardiothoracic or non-neurosurgical surgery requiring tracheal intubation for general anesthesia were enrolled. Ten patients per group were assigned to ciprofol-0.3, 0.4 and 0.5 mg/kg, and propofol-2.0 or 2.5 mg/kg groups, respectively to receive an intravenous bolus dose. An additional 20 patients were enrolled in the ciprofol-0.3, 0.5 or propofol-2.0 mg/kg groups. The primary outcome was the success rate of induction defined as a Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) ≤ 1 after the initial bolus dose. The secondary outcomes included the time to reach MOAA/S ≤ 1, the time to loss of the eyelash reflex, the incidences and severity of adverse events (AEs). | PMC10147789 |
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Results | The success rates were 100% for all 5 groups. The mean time to MOAA/S ≤ 1 and the time to loss of the eyelash reflex were not different among the 5 groups, regardless of whether a top-up dose was needed. There were no significant differences in the incidences and severity of AEs in the dose ranges investigated of ciprofol vs. propofol. | PMC10147789 |
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Conclusion | The efficacy and safety of a single bolus dose of ciprofol-0.5 mg/kg for the general anesthesia induction in selective surgery patients was comparable to that of propofol-2.0 mg/kg. | PMC10147789 |
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Trial registration | Clinicaltrials.gov, NCT03698617, retrospectively registered. | PMC10147789 |
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Supplementary Information | The online version contains supplementary material available at 10.1007/s11096-022-01529-x. | PMC10147789 |
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Keywords | PMC10147789 |
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Impact statements |
Propofol is commonly used for procedural sedation, but since it has the disadvantage of a narrow therapeutic index, alternative sedation drugs with improved drug dosing properties are desirable.Ciprofol is a novel drug for procedural sedation and general anesthesia with a potency about 4–5 times higher than propofol, which reduces the necessary amount of active drug required to induce sedation compared to propofol.In this phase 2a clinical trial, 0.5 mg/kg ciprofol had similar outcomes to 2.0 mg propofol but a future randomized study is warranted. | PMC10147789 |
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Introduction | Propofol is commonly used for procedural sedation [Ciprofol emulsion (HSK3486), a 2, 6-disubstituted phenol derivative [We assumed that ciprofol would have a similar success rate to propofol for the induction of general anesthesia and here we also provide guidance for its the clinical applications. | PMC10147789 |
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Aim | Based on previous phase 2 results, in this phase 2 study, we aimed to: (1) determine the equally potent dose of ciprofol compared with propofol as an induction agent for general anesthesia in patients undergoing selective surgery; and (2) to assess its safety. | PMC10147789 |
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Ethics approval | WEST | The study was approved by the Institutional Review Board (IRB) of Peking University First Hospital (Approval No. 2016-46; December 28th, 2016), West China Hospital, Sichuan University (Approval No. 2017-32; January 15th, 2018) and all other participating medical centers. Prior written informed consent was obtained from all participants in the trial. | PMC10147789 |
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Method | PMC10147789 |
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Study design and patients | This was a phase 2a, 7-center, open-labeled, non-randomized and positive controlled clinical trial. The study consisted of two parts: part 1, dose escalation and part 2, dose expansion. The trial was registered at clinicaltrials.gov (NCT03698617).The inclusion criteria for participants were: 18–65 years old; non-pregnant and non-lactating if female; body mass index (BMI) 19–30 kg/m | PMC10147789 |
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Part I: Dose escalation | In a previous phase 1 study, the results indicated that ciprofol 0.4 mg/kg, administered as a single i.v. bolus dose, was suitable for inducing general anesthesia in healthy adults. Therefore, in this phase 2a study, we chose 3 doses of ciprofol (0.3, 0.4, 0.5 mg/kg) and 2 doses of propofol (2.0, 2.5 mg/kg). The plan was to enroll 10 patients in each group, with 0.4 mg/kg ciprofol selected as the initial escalation dosage, based on the results of a phase 1 study. If 10 patients in the ciprofol 0.4 mg/kg all successfully achieved 100% induction of anesthesia with a single bolus injection, the next step was administration of a single dose of 0.3 mg/kg for induction, with a dose reduction of 0.1 mg/kg for the 10 patients (ciprofol 0.3 mg/kg group). If one or more of the 10 patients who received a dose of 0.4 mg/kg failed to achieve satisfactory anesthesia, a dose of 0.5 mg/kg was given to another 10 patients, with an increment in the dose of 0.1 mg/kg (ciprofol 0.5 mg/kg group). It should be noted that the investigator and sponsor needed to decide whether patients could receive the next dose, after they had evaluated the safety and efficacy outcomes of the previous dose. For propofol, doses of 2.0 mg/kg and 2.5 mg/kg were arbitrarily chosen as guided by a previous study [Finally, 9, 8 and 8 patients were scheduled to be enrolled in the 3 ciprofol groups and 10 in each propofol group. | PMC10147789 |
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For top-up doses and numbers selection | The sedation level was assessed using the Modified Observer’s Assessment of Alertness/Sedation scores (MOAA/S) [ | PMC10147789 |
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Part II: Dose expansion | Upon completion of the part I study, a part 2 study was performed. Based on the results of the 5 groups (n = 10 for each group the study started with), an additional 20 patients were planned to be enrolled in each of the ciprofol-0.3, 0.5 mg/kg and propofol-2.0 mg/kg groups, respectively. | PMC10147789 |
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