Remifentanil Versus Propofol With Target Controlled Infusion Effect Site for the Sedation of Patients During Gastrointestinal Endoscopic Procedures: Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Patient satisfaction
研究概览
简要总结
The purpose of this study was to compare remifentanil and propofol for sedation of patients during endoscopic gastrointestinal procedures.
详细描述
The administration of sedation with target controlled infusion (TCI) systems could offer a safe alternative for the management of discomfort of patients undergoing endoscopic gastrointestinal procedures. However, what medication from those available for TCI would be the most appropriate is not known.
Sixty-nine patients requiring a gastrointestinal endoscopic procedure were randomly assigned to receive a TCI effect site (e) of remifentanil (n=30) or propofol (n=39). The primary outcome was patient satisfaction. Secondary outcomes included gastroenterologist satisfaction, the proportion of adverse events between the two groups were compared (occurrence of cardiac arrhythmias, mild respiratory depression, major respiratory depression, bradycardia, hypotension, pain, nausea or vomiting, and lack of amnesia), and the level of consciousness.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing elective higher, lower or mixed gastrointestinal endoscopy at Hospital de San Jose, Bogota, between January and December
- •Be between 18 and 70 years old.
- •American Society of Anesthesiology Physical Status classification between 1 and
- •Provide written informed consent.
排除标准
- •Patients with difficult airway indicators.
- •Pregnant women.
- •Patients with chronic pain.
- •Chronic opioid or benzodiazepine users (>3 months).
- •Allergy history to remifentanil or propofol or eggs.
- •Psychoactive drug users.
- •Smokers (> 5 cigarettes per day in the previous 3 months).
- •Body mass index > 30.
研究组 & 干预措施
Remifentanil
Remifentanil target controlled infusion effect site with Minto's pharmacokinetic model.
Start dose: 1 ng/mL. Titration: 0.5 ng/mL according to clinical criteria.
干预措施: Remifentanil (Drug)
Propofol
Propofol target controlled infusion effect site with Marsh's pharmacokinetic model.
Start dose: 1 mcg/mL. Titration: 0.5 mcg/mL according to clinical criteria.
干预措施: Propofol (Drug)
结局指标
主要结局
Patient satisfaction
时间窗: At the end of the procedure, expected average of 30 minutes
Measured with a analog scale from 1 to 4: 1. Excellent. 2. Good. 3. Regular. 4. No.
次要结局
- Gastroenterologist satisfaction(At the end of the procedure, expected average of 30 minutes)
- Adverse events(At the end of the procedure, expected average of 30 minutes)