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

Sait Fatih Öner

Status: Completed

Conditions: Postoperative Recovery; Ambulatory Gynecologic Surgery; Cognitive Recovery; Sedation

Treatments: Drug: Propofol-Fentanyl; Drug: Propofol + Ketamine + Fentanyl (Ketofol); Drug: Ketamine-Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT07267377

no.258551508 ( November 5, 2024;Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

Propofol-Fentanyl Group

Active Comparator group

Description:

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

Treatment:

Drug: Propofol-Fentanyl

Ketamine-Fentanyl Group

Active Comparator group

Description:

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

Treatment:

Drug: Ketamine-Fentanyl

Propofol + Ketamine + Fentanyl Group (Ketofol)

Active Comparator group

Description:

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

Treatment:

Drug: Propofol + Ketamine + Fentanyl (Ketofol)