## Protocol Section
### Identification Module
**NCT ID:** NCT06412861

**Brief Title:** Propofol-ketamine or Propofol-fentanyl for Procedural Sedation in the Short-term Gynecological Case

**Official Title:** Comparison of Propofol-ketamine and Propofol-fentanyl Sedation in Short-term Gynecological Cases

#### Organization Study ID Info
**ID:** ilke
#### Organization
**Class:** OTHER
**Full Name:** Ondokuz Mayıs University
### Status Module
#### Completion Date
**Date:** 2024-06-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-05-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-20

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ondokuz Mayıs University

#### Responsible Party

**Investigator Affiliation:** Ondokuz Mayıs University

**Investigator Full Name:** Ilke Tamdogan

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Comparison of fentanyl-propofol and ketamine-propofol combination for sedation in brief gynecological cases

Our study aimed to evaluate ketamine-propofol and fentanyl-propofol combinations in short-term gynecological cases in terms of hemodynamic parameters, recovery, complications, patient and physician comfort.

**Detailed Description:** Procedural sedation is widely used in various medical procedures worldwide, aiming to suppress consciousness adequately and provide sufficient analgesia while preserving the patient's cardiorespiratory function during painful or unpleasant interventions (1,2). Many drugs are used alone or in combination for this purpose (e.g., benzodiazepines, opioids such as fentanyl and remifentanil, midazolam, ketamine, propofol, dexmedetomidine) (6). This prospective, randomized, double-blind study will evaluate the effectiveness of ketamine-propofol and fentanyl-propofol combinations during short-term gynecological procedures by comparing the frequency of lower extremity movements in sedated patients.

Participants eligible for the study will include individuals aged 18-65 with American Society of Anesthesiologists (ASA) physical status I or II undergoing short gynecological procedures lasting less than 30 minutes. Participants with allergies to study medications, obesity, or behavioral disorders will be excluded. All participants will provide written informed consent the day before the procedure.

Enrolled participants will be divided into two groups: Group K, receiving ketamine and propofol, and Group F, receiving fentanyl and propofol. Heart rate (HR), arterial blood pressure (ABP), peripheral oxygen saturation (SpO2), Ramsey Sedation Score( 1: Awake; agitated or restless or both, 2: Awake; cooperative, oriented, and tranquil,3: Awake but responds to commands only, 4: Asleep; brisk response to light glabellar tap or loud auditory stimulus,5: Asleep; sluggish response to light glabellar tap or loud auditory stimulus, 6: Asleep; no response to glabellar tap or loud auditory stimulus)( RSS), and Facial Pain Score(0:No hurt- 10:Hurts worst (FPS) will be evaluated at five time points: T1 (pre-induction), T2 (1 minute post-induction), T3 (3 minutes post-induction), T4 (end of surgery), and T5 (30 minutes postoperatively).

) In Group K, ketamine-propofol will be prepared in a 1:1 ratio (both 10 mg/mL) in the same syringe, while in Group F, fentanyl (1-2 mcg/kg) and propofol (1 mg/kg) will be prepared separately. Sedation will be initiated with 0.2 mL/kg of ketofol. Surgery will commence if RSS \> 4; if the desired sedation level is not achieved, a rescue dose of 0.5 mg/kg propofol bolus will be administered.

### Conditions Module

**Conditions:**

- Ketamine

- Sedation

- Gynecologic Disease

**Keywords:**

- ketamine

- sedation

- gynecological case

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Patients will be randomly assigned to one of two groups (1:1 ratio, parallel randomization) by randomization using the computer program "ResearchRandomizer" (Urbaniak and Plous 2013), conducted by a team member not involved in surgery or patient assessment. There will be 30 patients in each group.

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 0.5 mg/kg ketamine + 1 mg/kg propofol will be administered. Ramsey Sedation Score will be targeted to be \> 4. For this, if necessary, additional iv 0.5 mg/kg propofol will be administered.

**Intervention Names:**

- Drug: Ketamine

**Label:** ketamine-propofol

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** 1 mcg/kg fentanyl + 1 mg/kg propofol will be administered. Ramsay Sedation Score will be targeted to be \> 4. For this, if necessary, additional iv 0.5 mg/kg propofol will be administered.

**Intervention Names:**

- Drug: Fentanyl

**Label:** fentanyl-propofol

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- ketamine-propofol

**Description:** 0.5 mg/kg ketamine + 1 mg/kg propofol, Ramsey Sedation Score \> 4 will be targeted. For this, if necessary, additional iv 0.5 mg/kg propofol will be administered.

**Name:** Ketamine

**Other Names:**

- GROUP A

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- fentanyl-propofol

**Description:** 1 mcg/kg fentanyl + 1 mg/kg propofol will be administered. Ramsay Sedation Score will be targeted to be \> 4. For this, if necessary, additional iv 0.5 mg/kg propofol will be administered.

**Name:** Fentanyl

**Other Names:**

- GROUP B

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Surgical satisfaction survey:

Was the level of sedation sufficient during local anesthesia administration? Was the level of sedation sufficient throughout the surgical procedure? Was your verbal communication level with the patient sufficient? Would you recommend this sedation method to other surgeons for this surgical procedure? Would you accept using the same sedation technique for your next surgical procedure with the patient? Scoring: Ratings are based on a scale of 0 to 2, where 0 indicates 'not at all', 1 indicates 'somewhat', and 2 indicates 'completely'. The scores are evaluated on a scale from the lowest '0' to the highest '10'."

**Measure:** Surgical satisfaction

**Time Frame:** Postoperative procedure

**Description:** The incidence of lower extremity movement indicative of inadequate sedation or analgesia during the procedure

**Measure:** Incidence of lower extremity movement during the procedure

**Time Frame:** intraoperative

#### Secondary Outcomes

**Description:** he side effects occurring during the intraoperative and postoperative periods include:

Recall events (recall of events during surgery) Apnea (holding breath for \>15 seconds) Desaturation (SpO2 \< 96%) Jaw thrust maneuver Bradycardia (heart rate \< 50 beats/min) Skin rash

**Measure:** Adverse events (such as nausea, vomiting, airway obstruction, apnea, desaturation, respiratory depression, hypotension and bradycardia)

**Time Frame:** 30th minute postoperative

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients between the ages of 18-65,
* American Society of Anesthesiologists (ASA) I-II,

Exclusion Criteria:

* Patients with a known allergy to any of the drugs used in the study,
* Renal, hepatic, neuro-psychiatric, cardiovascular, or respiratory diseases, i
* intracranial space-occupying lesions,
* Pregnant women,
* Body mass index (BMI) \> 30

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** drilkeipek@gmail.com

**Name:** İlke Tamdoğan

**Phone:** 905062916678

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Samsun

**Contacts:**

***Contact 1:***

- **Name:** ilke tamdoğan

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Ondokuz Mayıs University Faculty of Medicine

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** ndokuz Mayıs University Faculty of Medicine

**Name:** ilke tamdoğan

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Sa Rego MM, Watcha MF, White PF. The changing role of monitored anesthesia care in the ambulatory setting. Anesth Analg. 1997 Nov;85(5):1020-36. doi: 10.1097/00000539-199711000-00012. No abstract available.

**PMID:** 9356094

**Citation:** Badrinath S, Avramov MN, Shadrick M, Witt TR, Ivankovich AD. The use of a ketamine-propofol combination during monitored anesthesia care. Anesth Analg. 2000 Apr;90(4):858-62. doi: 10.1097/00000539-200004000-00016.

**PMID:** 10735789

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000091662

- Term: Genital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: HIGH

- As Found: Gynecologic Disease

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005831

- Term: Genital Diseases, Female

### Intervention Browse Module - Ancestors

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000778

- Term: Anesthetics, Dissociative

- ID: D000018686

- Term: Anesthetics, Intravenous

- ID: D000018681

- Term: Anesthetics, General

- ID: D000000777

- Term: Anesthetics

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000018691

- Term: Excitatory Amino Acid Antagonists

- ID: D000018683

- Term: Excitatory Amino Acid Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000701

- Term: Analgesics, Opioid

- ID: D000009294

- Term: Narcotics

- ID: D000000759

- Term: Adjuvants, Anesthesia

### Intervention Browse Module - Browse Branches

- Abbrev: AdjAn

- Name: Adjuvants, Anesthesia

- Abbrev: Analg

- Name: Analgesics

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M8418

- Name: Fentanyl

- Relevance: HIGH

- As Found: Scan

- ID: M10674

- Name: Ketamine

- Relevance: HIGH

- As Found: Provided

- ID: M18307

- Name: Propofol

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M4108

- Name: Anesthetics, Dissociative

- Relevance: LOW

- As Found: Unknown

- ID: M20766

- Name: Anesthetics, Intravenous

- Relevance: LOW

- As Found: Unknown

- ID: M20761

- Name: Anesthetics, General

- Relevance: LOW

- As Found: Unknown

- ID: M20771

- Name: Excitatory Amino Acid Antagonists

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4033

- Name: Analgesics, Opioid

- Relevance: LOW

- As Found: Unknown

- ID: M12245

- Name: Narcotics

- Relevance: LOW

- As Found: Unknown

- ID: M4089

- Name: Adjuvants, Anesthesia

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000005283

- Term: Fentanyl

- ID: D000007649

- Term: Ketamine

### Misc Info Module

- Version Holder: 2024-05-31
