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Completed

NCT Number: NCT07267377

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

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.

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Key information

Conditions

Cognitive Recovery Ambulatory Gynecologic Surgery Postoperative Recovery Sedation

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fethi Sekin City Hospital

Elâzığ, Elaziğ, 23050, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Propofol (Diprivan), Fentanyl (Fentanyl Citrate)

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.

Other names: Ketamine (Ketalar) Fentanyl (Fentanyl Citrate)

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.

Other names: Propofol (Diprivan) Ketamine (Ketalar) Fentanyl (Fentanyl Citrate)

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Sait Fatih Öner

Other

Registry information

Official study title

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

Acronym: SEDCOG

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 5, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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