Effects of Sedation Techniques on Early Cognitive Recovery in Ambulatory Gynecologic Surgery: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Mini-Mental State Examination (MMSE) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
盲法说明
Both the participants and the investigators administering sedation were blinded to the group assignments.
Sedative solutions were prepared in identical syringes by an independent anesthesiologist not involved in data collection or analysis.
The assessing investigator was unaware of the sedative regimen used for each patient.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Propofol-Fentanyl Group
Induction propofol 0.5 mg/kg + fentanyl 1 µg/kg; maintenance propofol 0.25 mg/kg as intermittent boluses to maintain RSS=3
干预措施: Propofol-Fentanyl (Drug)
Ketamine-Fentanyl Group
Induction ketamine 0.5 mg/kg + fentanyl 1 µg/kg; maintenance ketamine 0.25 mg/kg as intermittent boluses
干预措施: Ketamine-Fentanyl (Drug)
Propofol + Ketamine + Fentanyl Group (Ketofol)
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
干预措施: Propofol + Ketamine + Fentanyl (Ketofol) (Drug)
结局指标
主要结局
Change in Mini-Mental State Examination (MMSE) Score
时间窗: 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.
次要结局
未报告次要终点
研究者
Sait Fatih Öner
Principal Investigator
Elazıg Fethi Sekin Sehir Hastanesi