Nurse-Administered Propofol Sedation by PCA Pump Versus Diazemuls / Pethidine in Outpatient Colonoscopy: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 194
- 主要终点
- Pain
研究概览
简要总结
Colonoscopy is a common endoscopic procedure as an investigation of colorectal pathology. Different modalities of pain control have been described in the past. Propofol is a perfect drug for endoscopic procedure since it has the characteristic of fast onset, short half-life and early recovery. Its unfamiliarity and its potential cardiovascular and respiratory side effect make it unpopular to endoscopists. Recent reports showed propofol is safe in bolus titration by nurse in Caucasian in all endoscopic procedures. Our previous pilot study showed nurse administered propofol sedation (NAPS) is effective and safe and highly acceptable by Chinese patients. Here we conduct a randomized controlled study to compare the effectiveness of NAPS versus traditional sedation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 undergoing elective outpatient colonoscopy
排除标准
- •American Society of Anesthesiologist Class III or above
- •History of difficult endotracheal intubation
- •Known allergy to propofol, eggs or soy products, opioid, benzodiazepines
- •previous colectomy
研究组 & 干预措施
1
Diazemuls-Pethidine
干预措施: diazemuls, pethidine (Drug)
2
Propofol- Alfentanil
干预措施: Propofol and Alfentanil (Drug)
结局指标
主要结局
Pain
时间窗: after recovery
次要结局
- sedation(thorughout the procedure)