Phase IV Study of Propofol TCI (Target Controlled Infusion)Administered by Gastroenterologists During Endoscopy in Moderate Sedation: a Randomized Double Blind Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Endoscopist's VAS (Visual Analog Scale) satisfaction about propofol TCI moderate sedation
研究概览
简要总结
Many studies address safety and effectiveness of non-anesthesiologist propofol sedation (NAPS) for GI endoscopy. Target Controlled Infusion (TCI) is a sophisticated tool for providing optimal sedation regimen and avoiding under or oversedation.
This randomized double blind controlled study compares standard moderate sedation level of sedation (group S) during upper endoscopy (EGD) and colonoscopy (CS) versus propofol NAPS (group P).
详细描述
70 CS and 70 EGD ASA I-II patients were studied. In group S (n=70) we administered fentanyl (1μg/kg) + midazolam (0.04-0.03 mg/kg) for CS and midazolam (0.04-0.03 mg/kg) for EGDS and in group P (n=70) fentanyl 1µg/Kg + propofol TCI 1.2-1.6 μg/ml for CS and propofol TCI 1.2-1.6 μg/ml for EGD. Vital parameters and Observer's Assessment of Alertness and Sedation Scale (OAA/S) were monitored throughout the study. Endoscopist's and patient's satisfactions were measured after procedure and 24-72 h later by visual analog scale (VAS).
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, Care Provider)
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 yrs
- •ASA (American Society of Anesthesiologists risk class III-IV)I-II
- •patients undergoing to gastroscopy or colonoscopy
排除标准
- •significant systemic disease (American Society of Anesthesiologists risk class III-IV)
- •history of allergic reactions to any of the study drugs
- •chronic use of opioid analgesics
- •psychiatric disorder
- •pregnancy
- •difficult airways (Mallampati score >2)
- •age <18 yrs
研究组 & 干预措施
propofol
Patients in Group Propofol(n=70) were seated with propofol target concentration 1.2-1.6 µg/ml. Patients in both groups undergoing CS received also iv fentanyl (1μg/Kg) for pain control.
干预措施: Propofol (Drug)
propofol
Patients in Group Propofol(n=70) were seated with propofol target concentration 1.2-1.6 µg/ml. Patients in both groups undergoing CS received also iv fentanyl (1μg/Kg) for pain control.
干预措施: Target Controlled Infusion (Device)
midazolam
Control Group: patients in Group midazolam (n=70) were sedated with midazolam 0.04 mg/kg if aged< 70 - 0.03 mg/kg if aged> 70. Patients in both groups undergoing CS received also iv fentanyl (1μg/Kg) for pain control.
干预措施: Midazolam (Drug)
结局指标
主要结局
Endoscopist's VAS (Visual Analog Scale) satisfaction about propofol TCI moderate sedation
时间窗: one day
Endoscopist's satisfaction was measured after endoscopic procedures by visual analog scale (VAS 0-100).
Patient's VAS (Visual Analog Scale) satisfactions about propofol TCI moderate sedation
时间窗: one day
Patient's satisfactions were measured after endoscopic procedures and 24-48 hours later by visual analog scale (VAS 0-100).
次要结局
- Safety (number of partecipants with adverse events) of propofol TCI moderate sedation(one day)
- Time to dischargeability (minutes to reach Modified Aldrete score ≥ 18) of patients(one day)
研究者
Agostoni Massimo
MD
Ospedale San Raffaele