Phase 4 Study of Balanced Propofol Sedation Versus Propofol Alone Sedation
试验速览
- 阶段
- 4 期
- 入组人数
- 204
- 主要终点
- Recovery time and cost-effectiveness
研究概览
简要总结
Based on previous results, the investigators considered that sedation quality, complications, and procedure outcomes may not be different, however, propofol alone titration may have a fast recovery time than BPS and cost-effectiveness than balanced propofol sedation (BPS). In present study, the investigators therefore evaluate the time and sedation quality of patient recovery, cost-effectiveness, complication, and procedure outcomes between propofol alone and BPS in therapeutic endoscopic retrograde cholangiopancreatography (ERCP).
详细描述
Previous studies have shown that propofol is superior to traditional sedation regimens with benzodiazepines plus opioids in ERCP procedures. Propofol is a potent hypnotic drug with a short duration of action and consequently a more rapid recovery time for the patients compared with the available Benzodiazepines. Several prospective studies have shown that balanced propofol sedation (BPS) can be used safely and effectively for diagnostic endoscopy under the direction of a gastroenterologist. BPS which was originally described by Cohen et al, combines small incremental doses of propofol with single induction doses of benzodiazepines and opioids under the direction of a physician that is not an anesthesiologist. Because BPS usually targets moderate sedation, adequate amnesia and analgesia can be achieved with concomitant administration of benzodiazepines and opioids. It may cause synergism between propofol and midazolam and reduce dose of propofol. However, there was no proven benefit between propofol alone titrated to moderate level of sedation and BPS; propofol titration combination with benzodiazepines and fentanyl.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •candidates for therapeutic ERCP
排除标准
- •patient age < 18 years
- •pregnant women
- •inability to provide informed consent
- •patients with total gastrectomy
- •American Society of Anesthesiologist (ASA) Class V patients
- •patients with known respiratory disease, patients with neurologic impairment
- •patients with known allergy to the drugs used, history of complications with previous sedation
研究组 & 干预措施
Propofol group
the conventional propofol group (P group), sedation was induced by an intravenous bolus injection of propofol (0.5 mg/kg body weight; 10 mg if age > 70 or ASA class III-IV).
干预措施: Propofol (Drug)
BPS group
the balanced propofol sedation group (BPS group), both midazolam (0.05 mg/kg body weight; 1 mg if age > 70 or ASA class III-IV) and fentanyl (50 µg; 25 µg if age > 70 or ASA class III-IV) were given intravenously at the initiation of sedation. Thereafter, an initial bolus of propofol (0.5 mg/kg body weight) was given intravenously. Sedation was maintained with repeated doses of 10 to 20 mg propofol.
干预措施: BPS (Drug)
结局指标
主要结局
Recovery time and cost-effectiveness
时间窗: SIX MONTH
Following therapeutic ERCP,full recovery time scoring by Aldrete scoring system and cost measured.
次要结局
- Sedation efficacy, procedure-related outcomes, and complications.(SIX MONTH)