Phase 4, Prospective, Randomized, Double-blinded, Placebo-controlled Study Comparing Propofol vs. Midazolam Plus Propofol for Nonanesthesiologist Targeted Moderate Sedation in Outpatient Colonoscopy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Level of Sedation Throughout the Entire Procedure
研究概览
简要总结
Nonanesthesiologist administration of propofol for sedation is actually a field of growing interest for endoscopists, as demonstrated by recent American and European guidelines on this issue. Propofol is a hypnotic drug with rapid onset and offset of action. Used as a single agent, it is commonly titrated to deep sedation, whereas balanced propofol sedation (BPS), which combines propofol with small doses of a benzodiazepine and/or an opioid, can be successfully titrated to moderate sedation. However, nonanesthesiologists propofol administration remains controversial on account of the possibility of deep sedation/general anesthesia related adverse events. On the other hand, the use of longer elimination half-life drugs, such as opioids and benzodiazepines, may theoretically prolong sedation and recovery.
Up to date, no study has addressed a head-to-head comparison of both regimens administered by non-anesthesiologists and titrated to moderate sedation.
This study aims to evaluate the impact on propofol sedation of premedication with a fixed dose of midazolam (2 mg)2 minutes before propofol administration targeted to moderate sedation, in terms of depth of sedation, recovery times, safety and satisfaction.
The onset of sedative action of midazolam has been reported to be 1-2.5 minutes and the peak effect of midazolam occurs 8-12 minutes. Taking into account that colonoscopy usually lasts a minimum of 15-20 minutes, our hypothesis is that synergy between propofol and midazolam may increase the depth of sedation through the initial phases of the procedure, diminishing propofol requirements, but not prolonging significantly recovery times.
详细描述
Justification of the study:
Nonanesthesiologist administration of propofol is controversial owing to deep sedation concerns. One of the latest therapeutic innovations on this issue has been the development of balanced propofol sedation, which consists of adding low doses of opioids or benzodiazepins. Several studies have recently demonstrated that BPS allows successfully moderate sedation, maintains a reversible drug component, reduces the total dose of propofol even by more than 50% without increasing adverse events and maintains high levels of physician and patient satisfaction, even for advanced endoscopic procedure. However, recovery may be prolonged by using midazolam or meperidine as they have a longer elimination half-life than propofol has.
Up to date, nonanesthesiologist administration of propofol and BPS, using either midazolam or fentanyl, for outpatient colonoscopy have been compared in a single non-placebo controlled randomized trial (VanNatta and Rex, 2006). In this study, the authors obtained shorter recovery times with BPS compared to propofol alone, in contrast with the expected on account of pharmacokinetics. These results can be easily understood yet single-agent propofol was titrated to deep sedation, whereas BPS was titrated to moderate sedation.
Therefore, it is necessary to make a randomized, double-blinded, placebo-controlled trial to directly compare both sedation regimens targeted to a similar moderate level of sedation. The results of this study will conclude which should be the first line treatment for moderate sedation in colonoscopy, providing further insight in drug synergy and its impact on the depth of sedation and recovery times
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
- •All patients undergoing elective outpatient colonoscopy
排除标准
- •Age less than 18 years
- •Allergy to propofol, soybeans, eggs or midazolam
- •Chronic intake of benzodiazepines
- •History of colorectal surgery
- •ASA class IV, short and tick neck, difficult intubation due to inability to open the mouth widely
- •Pregnancy
- •Refusal, inability or unwillingness to give written consent
- •Patients scheduled for advanced therapeutic colonoscopy or for more than one endoscopic procedure
研究组 & 干预措施
Midazolam balanced propofol sedation
2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion
干预措施: Midazolam (Drug)
Single-agent propofol sedation
2 ml saline followed by continuous propofol iv infusion
干预措施: Propofol (Drug)
结局指标
主要结局
Level of Sedation Throughout the Entire Procedure
时间窗: Up to 1 hour after introduction of the colonoscope
Assessment every two minutes of the level of sedation during the endoscopic procedure, rating it as minimal, moderate or deep.
次要结局
- Duration of Recovery After the Endoscopic Procedure(Up to 1 hour after colonoscopy)
- Rate of Sedation-related Complications During the Procedure and the Recovery Phases(Up to two hours, including colonoscopy performance and recovery period)
- Rate of Patients and Physician Satisfaction With Sedation(Up to 1 hour after colonoscopy for endoscopists and up to 48 hours for patients)
研究者
Javier Molina-Infante, MD
Medical Doctor
Infante, Javier Molina, M.D.