Non-anesthesiologist Administered Propofol Sedation for Colonoscopy - a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 277
- 试验地点
- 1
- 主要终点
- Minor adverse events
研究概览
简要总结
Propofol is the preferred sedation for colonoscopy. There is debate on the safety of the administration of propofol by non-anesthesiologists, despite moderate quality evidence that support its' use.
There is only one small trial of a direct comparison of propofol sedation by anesthesiologists versus non-anesthesiologists.
Our aim is to compare the incidence of sedation related adverse events, the procedural quality indicators, times (onset, recovery, discharge) and patient satisfaction between non-anesthesiologist administered propofol sedation (NAAP) sedation and anesthesiologist propofol sedation.
A randomized clinical trial with the incidence of sedation related minor adverse events as primary endpoint will be conducted. Secondary endpoints include procedure quality indicators, propofol dosage and patient satisfaction.
A sample size of 330 subjects (2 arms of 165 patients) will be needed in order to obtain 90% power and a 5% significance level to exclude a 15% difference (15 - 30%) in adverse events incidence, estimated from our pilot experience. The sample size was adjusted for a 2% cross-over rate.
Informed and consenting patients undergoing colonoscopy examinations will be randomly assigned to one of two arms. One group will be sedated by an anesthesiologist according to a protocol of propofol mono-sedation. The other group will be sedated with propofol boluses, according to the European Society of Gastrointestinal Endoscopy (ESGE) NAAP guideline, with a 3-man team consisting of one endoscopist, one endoscopy nurse and a sedation nurse, trained in NAAP and exclusively dedicated to sedation and patient monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Referred for elective colonoscopy as outpatients
- •Must be able to provide the informed consent
排除标准
- •American Society of Anaesthesiologists (ASA) class >2
- •Pregnant women
- •Difficult airway predictors (more than 2 ou Mallampati >3)
- •Allergy to propofol or its' components
- •IV drugs abuse
研究组 & 干预措施
Non-anesthesiologist propofol sedation
Bolus propofol sedation by non-anesthesiologist
干预措施: Non-anesthesiologist propofol sedation (Drug)
Non-anesthesiologist propofol sedation
Bolus propofol sedation by non-anesthesiologist
干预措施: Colonoscopy (Procedure)
Anesthesiologist administered propofol
Propofol sedation administered by an anesthesiologist
干预措施: Propofol sedation administered by an anesthesiologist (Drug)
Anesthesiologist administered propofol
Propofol sedation administered by an anesthesiologist
干预措施: Colonoscopy (Procedure)
结局指标
主要结局
Minor adverse events
时间窗: During the sedation period
Minor adverse events as defined by the International Sedation Task Force, including peripheral O2 saturation between 75-90% for less than 60 seconds, apnea, airway obstruction, sedation failure, allergic reaction without anaphylaxis, convulsion, brady/tachycardia and hypo/hypertension (\>25% change from baseline)
次要结局
- Propofol dosage(During the colonoscopy - an estimated mean time of 20 minutes)
- Patient satisfaction(Before discharge - estimated mean recovery time of 1 hour)
- colonoscopy quality indicators(During the procedure)
- Patient satisfaction 2(Before discharge - estimated mean recovery time of 1 hour)
研究者
Alexandre Ferreira
Dr
Hospital Beatriz Ângelo