Loading clinical trials...
Loading clinical trials...
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.
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.
Age
18 - 60 years
Sex
FEMALE
Healthy Volunteers
No
Fethi Sekin City Hospital
Elâzığ, Elaziğ, Turkey (Türkiye)
Start Date
December 15, 2024
Primary Completion Date
July 1, 2025
Completion Date
September 15, 2025
Last Updated
December 16, 2025
120
ACTUAL participants
Propofol-Fentanyl
DRUG
Ketamine-Fentanyl
DRUG
Propofol + Ketamine + Fentanyl (Ketofol)
DRUG
Lead Sponsor
Sait Fatih Öner
NCT07461376
NCT07269808
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions