Effects of Different Sedation Techniques on Early Cognitive Recovery After Ambulatory Gynecologic Surgery
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.
Timeline
- Start
- 2024-12-15
- Primary completion
- 2025-07-01
- Completion
- 2025-09-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ketamine | Small molecule | 0.25 mg/kg | Intravenous |
| Comparator | Propofol | Small molecule | 0.25 mg/kg | Intravenous |
| Comparator | Fentanyl | Other / unclassified | 1 ug/kg | Intravenous |
Indications
No indication recorded.