The Influence of Sedation for Endoscopy on Cognitive Function
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- NCT-A test outcome measure
研究概览
简要总结
It is commonly recommended that patients should refrain from driving for 24 hours after sedation for endoscopy，however，this recommendation has been queried recently．To investigate the effect of sedation on early postoperative cognitive function in patients undergoing endoscopy.
详细描述
One hundred adult patients undergoing sedative esophagogastroduodenoscopy ( EGD) were randomly recruited，and another 100 adult patients undergoing conventional（without sedation） EGD were served as controls． All patients had an education level more than 9 years． Cognitive function was assessed by Montreal Cognitive Assessment（MoCA）1 week before EGD exam, 10 mins before propofol sedation or the beginning of endoscopic procedure, 30mins after EGD exam, and 2 week after exam.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The scores of MMSE are more than
- •The AHA grade I and II.
排除标准
- •The AHA grade III, IV or V.
- •binge drinking.
- •Take sedatives, sleeping agents and some drug which may affect the study in a month.
- •Psychiatric disorders.
- •The dysfunction of heart, lung, liver and kidney.
研究组 & 干预措施
sedation group
Patients undergo sedative esophagogastroduodenoscopy (EGD) and are intravenous injected propofol in bolus
干预措施: endoscopy (Device)
control group
patients undergo conventional EGD
干预措施: endoscopy (Device)
sedation group
Patients undergo sedative esophagogastroduodenoscopy (EGD) and are intravenous injected propofol in bolus
干预措施: Propofol (Drug)
结局指标
主要结局
NCT-A test outcome measure
时间窗: 30 minutes
the score of NCT-A test for each patient is not less than that in the baseline.
DST test outcome measure
时间窗: 30 minutes
the score of DST for each patient is not less than that in the baseline.
number cancellation test outcome measure
时间窗: 30 minutes
the score of number cancellation test for each patient is not less than that in the baseline.
次要结局
- SpO2 outcome measure(5 minutes)
- heart rate outcome measure(5 minutes)
研究者
Zhizheng Ge
Ren Ji Hospital, School of medicine, Shanghai Jiao Tong University
Shanghai Jiao Tong University School of Medicine