Propofol Administered by Gastroenterologists by Target Controlled Infusion Pump During Endoscopy: a Randomized Double Blind Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Endoscopist's Satisfaction (Visual Analog Scale) About Sedation
研究概览
简要总结
Many studies address safety of non-anesthesiologist propofol sedation (NAPS) for gastrointestinal endoscopy. Target Controlled Infusion (TCI) is a sophisticated tool for providing optimal sedation regimen and avoiding under or oversedation. The objective of the study is to compare standard moderate sedation during upper endoscopy and colonoscopy versus propofol NAPS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age < 18 years
- •American Society of Anesthesiologists risk I-II
- •patients undergoing to Gastroscopy or Colonoscopy
排除标准
- •significant systemic disease
- •allergic reactions to any of study drugs
- •chronic use of opioids or psychiatric disorders
- •pregnancy
- •Mallampati score > 2
- •age < 18 years
研究组 & 干预措施
propofol group
70 patients (35 upper endoscopy - 35 colonoscopy)
干预措施: Propofol (Drug)
midazolam group
70 patients (35 upper endoscopy - 35 colonoscopy)
干预措施: Midazolam (Drug)
结局指标
主要结局
Endoscopist's Satisfaction (Visual Analog Scale) About Sedation
时间窗: at the end of the exam
Visual Analog Scale from 0 to100 (0=dissatisfaction - 100=complete satisfaction) will be used to assess the technical difficulty of examination and the satisfaction with sedation of patient experienced by endoscopist
Patient's Satisfaction (Visual Analog Scale) About Sedation 24-72 Hours After Procedure
时间窗: at 24-72 hours after procedure
Patients will be contacted by telephone 24-72 hours after discharge and asked about their satisfaction about the quality of sedation, rated on a verbal rating scale, from 0 to 100 (0=dissatisfaction; 100=complete satisfaction)
Patient's Satisfaction (Visual Analog Scale) About Sedation Before Discharge
时间窗: before discharge
When completely awake, patients will be asked to rate the degree of pain/discomfort and the degree of satisfaction about quality of sedation from 0 to100 (0=dissatisfaction - 100=complete satisfaction)
次要结局
- Number of Participants With Adverse Events as a Measure of Safety(one day)
- Time (Minutes) to Dischargeability of Patient From Endoscopic Unit(one day)
研究者
Testoni Pier Alberto
Professor
Università Vita-Salute San Raffaele