NCT07267377

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Sait Fatih Öner · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cognitive Recovery
• Sedation
• Ambulatory Gynecologic Surgery
• Postoperative Recovery

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2024-12-15
• Primary completion: 2025-07-01
• Completion: 2025-09-15
• First posted: 2025-12-05
• Last updated: 2025-12-16

Locations

1 site across 1 country: Turkey (Türkiye)