Effects of Different Sedation Techniques on Early Cognitive Recovery After Ambulatory Gynecologic Surgery

NCT07267377 | Completed

• 1 other identifier: no.258551508; November 5, 2024
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, randomized, double-blind clinical trial aims to compare the effects of three commonly used sedoanalgesia regimens on early cognitive recovery in patients undergoing ambulatory gynecologic surgery (dilatation and curettage). The main objective of the study is to determine whether the use of propofol-fentanyl, ketamine-fentanyl, or their combination (ketofol-fentanyl) influences the recovery of cognitive functions during the early postoperative period. The primary outcome is the change in the Mini-Mental State Examination (MMSE) score between baseline and recovery. Secondary outcomes include awakening time, Aldrete recovery score (ARS), pain intensity using the visual analog scale (VAS) at 10 and 30 minutes, hemodynamic parameters, and adverse events. Participants will be randomly assigned to one of three groups: Group P: Propofol-fentanyl Group K: Ketamine-fentanyl Group KP: Propofol + ketamine + fentanyl All patients will receive sedation to achieve a Ramsay Sedation Scale score of 3-4. Cognitive function will be assessed preoperatively and after recovery in the post-anesthesia care unit. The study seeks to determine whether the combined use of ketamine and propofol provides any advantage in cognitive recovery or hemodynamic stability compared to single-agent sedation.

Conditions

Cognitive Recovery; Sedation; Ambulatory Gynecologic Surgery; Postoperative Recovery

Keywords

Propofol; Ketamine; Ketofol; Sedoanalgesia; Cognitive Recovery; Ambulatory Surgery; Gynecologic Surgery; Postoperative Recovery; Mini-Mental State Examination

Outcome Measures

Primary Outcomes (1)

• Change in Mini-Mental State Examination (MMSE) Score

  Difference between baseline and postoperative MMSE scores measured before sedation and at recovery in the post-anesthesia care unit (PACU). The MMSE assesses early cognitive recovery after ambulatory gynecologic surgery under sedation.

  Baseline and recovery (within approximately 60 minutes post-sedation)

Study Arms (3)

Propofol-Fentanyl Group

ACTIVE COMPARATOR

Induction propofol 0.5 mg/kg + fentanyl 1 µg/kg; maintenance propofol 0.25 mg/kg as intermittent boluses to maintain RSS=3

Drug: Propofol-Fentanyl

Ketamine-Fentanyl Group

ACTIVE COMPARATOR

Induction ketamine 0.5 mg/kg + fentanyl 1 µg/kg; maintenance ketamine 0.25 mg/kg as intermittent boluses

Drug: Ketamine-Fentanyl

Propofol + Ketamine + Fentanyl Group (Ketofol)

ACTIVE COMPARATOR

Induction ketofol 0.75 mg/kg (1:1 mixture of propofol 10 mg/mL and ketamine 50 mg/mL, freshly prepared in a single syringe) + fentanyl 1 µg/kg; maintenance ketofol 0.25 mg/kg as intermittent boluses

Drug: Propofol + Ketamine + Fentanyl (Ketofol)

Interventions

Propofol-Fentanyl DRUG

Intravenous administration of propofol 0.5 mg/kg + fentanyl 1 µg/kg for sedation during ambulatory dilation and curettage (D\&C). This regimen represents the standard sedoanalgesia practice for gynecologic day-case procedures and serves as one of the comparison arms in the study.

Also known as: Propofol (Diprivan), Fentanyl (Fentanyl Citrate)

Propofol-Fentanyl Group

Ketamine-Fentanyl DRUG

Intravenous administration of ketamine 0.5 mg/kg + fentanyl 1 µg/kg for sedation during ambulatory dilation and curettage (D\&C). This arm evaluates the effects of ketamine-based sedoanalgesia on cognitive and hemodynamic recovery compared with other regimens.

Also known as: Ketamine (Ketalar) Fentanyl (Fentanyl Citrate)

Ketamine-Fentanyl Group

Propofol + Ketamine + Fentanyl (Ketofol) DRUG

Intravenous co-administration of propofol 0.5 mg/kg, ketamine (0.5 mg/kg), and fentanyl (1 µg/kg) for sedation during ambulatory dilation and curettage (D\&C). This combination (known as "Ketofol") aims to balance the sedative and hemodynamic effects of propofol and ketamine, and is compared with single-agent sedoanalgesia regimens.

Also known as: Propofol (Diprivan) Ketamine (Ketalar) Fentanyl (Fentanyl Citrate)

Propofol + Ketamine + Fentanyl Group (Ketofol)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients aged 18-60 years
• ASA physical status I-III
• Scheduled for ambulatory dilation and curettage (D\&C) under sedoanalgesia
• No neurological or psychiatric disorders

You may not qualify if:

• History of neurological, psychiatric, or cognitive disorders
• Inability to complete or comprehend cognitive assessment tests (MMSE)
• Known drug or alcohol abuse
• Pregnancy
• Severe hepatic or renal dysfunction

Sponsors & Collaborators

• Sait Fatih Öner: lead

Study Sites (1)

Fethi Sekin City Hospital

Elâzığ, Elaziğ, 23050, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Propofol; Fentanyl; Ketamine

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both the participants and the investigators administering sedation were blinded to the group assignments. Sedative solutions were prepared in identical syringes by an independent anesthesiologist not involved in data collection or analysis. The assessing investigator was unaware of the sedative regimen used for each patient.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study uses a parallel assignment model with three groups of participants. Each group receives a different sedoanalgesic regimen: propofol-fentanyl, ketamine-fentanyl, or propofol + ketamine + fentanyl (ketofol). Outcomes related to early cognitive recovery and hemodynamic stability are compared among the groups.

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 5, 2025
• Study Start: December 15, 2024
• Primary Completion: July 1, 2025
• Study Completion: September 15, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)