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

December 8, 2025 updated by: Sait Fatih Öner

Effects of Sedation Techniques on Early Cognitive Recovery in Ambulatory Gynecologic Surgery: A Prospective Randomized Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Early postoperative cognitive recovery is an important indicator of patient safety and discharge readiness in ambulatory anesthesia. Various sedative-analgesic combinations are used for gynecologic day-case procedures; however, their effects on early cognitive recovery remain unclear.

This prospective, randomized, double-blind clinical trial was conducted to compare the effects of three commonly used sedoanalgesia regimens - propofol-fentanyl, ketamine-fentanyl, and their combination (ketofol-fentanyl) - on postoperative cognitive function recovery after dilation and curettage (D&C).

A total of 108 ASA physical status I-III patients aged 18-60 years were included and randomly allocated into three groups (n=36 each). Sedation was titrated to maintain a Ramsay Sedation Scale (RSS) score of 3-4. Cognitive function was assessed preoperatively and postoperatively using the Mini-Mental State Examination (MMSE).

The primary outcome was the change in MMSE score between baseline and recovery. Secondary outcomes included awakening time, Aldrete recovery score (ADS), visual analog scale (VAS) pain score at 10 and 30 minutes, hemodynamic stability, and adverse events.

The study aimed to identify the sedative regimen that optimizes cognitive recovery and minimizes side effects in ambulatory gynecologic anesthesia, contributing to safer and faster discharge decisions.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Elaziğ
      • Elâzığ, Elaziğ, Turkey (Türkiye), 23050
        • Fethi Sekin City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Propofol-Fentanyl Group
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

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.

Other Names:
  • Propofol (Diprivan)
  • Fentanyl (Fentanyl Citrate)
Active Comparator: Ketamine-Fentanyl Group
Induction ketamine 0.5 mg/kg + fentanyl 1 µg/kg; maintenance ketamine 0.25 mg/kg as intermittent boluses
Drug: Ketamine-Fentanyl

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.

Other Names:
  • Ketamine (Ketalar) Fentanyl (Fentanyl Citrate)
Active Comparator: Propofol + Ketamine + Fentanyl Group (Ketofol)
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)

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.

Other Names:
  • Propofol (Diprivan) Ketamine (Ketalar) Fentanyl (Fentanyl Citrate)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Mini-Mental State Examination (MMSE) Score
Time Frame: Baseline and recovery (within approximately 60 minutes post-sedation)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sait Fatih Öner

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2024

Primary Completion (Actual)

July 1, 2025

Study Completion (Actual)

September 15, 2025

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

November 25, 2025

First Posted (Estimated)

December 5, 2025

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 8, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • no.258551508; November 5, 2024 (Other Identifier: Elazig Fethi Sekin City Hospital Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This study was conducted as a prospective, randomized, double-blind clinical trial at a single center.

Individual participant data (IPD) will not be shared because no consent for data sharing beyond the study team was obtained, and there is no approved external repository for data storage

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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