A Randomised Controlled Trial of "Light" Versus "Deep" Sedation for Elective Outpatient Colonoscopy: Recall, Procedural Conditions and Recovery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Recall of procedure
研究概览
简要总结
In this trial, patients undergoing elective colonoscopy under sedation will be randomised to BIS-guided sedation targeting either "light" (bispectral index [BIS] 70-80) or "deep" (BIS<60) sedation. Sedation will be achieved with a standardised regimen of target-controlled infusion of propofol and fentanyl bolus. The primary end point will be the incidence of procedure recall in each group - this will be assessed at the conclusion of the procedure. The procedural conditions, cardio-respiratory complications and recovery including cognitive function will be assessed during and immediately after the procedure. The incidence of dreaming and patient satisfaction with anaesthesia care will be recorded immediately after the procedure. The study will be complete when the patient leaves the hospital on the day of the procedure.
详细描述
Controversy exists about the need for deep sedation or light sedation during elective colonoscopy. Deep sedation ensures amnesia for the procedure and may ensure better operating conditions, but may result in cardiorespiratory side effects and prolonged recovery. Differences exist between countries regarding the prevailing depth of sedation with deeper sedation in general being administered in Australia than the United States. This study aims to explore that controversy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, 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
- •Plan for elective outpatient colonoscopy under sedation
- •Able and willing to provide written informed consent for study entry and completion of all study related procedures
- •American Society of Anesthesiologists' (ASA) physical status grade 1-3
排除标准
- •Colonoscopy and gastroscopy booked as joint procedures
- •Colonoscopy on emergency patients and/or inpatients
- •Inadequate English comprehension (verbal and written to understand the Participant Information and Consent Form)
- •Intellectual or psychiatric disability that prevents consent to and comprehension of study procedures
- •Significant cognitive impairment that prevents independent conduct of activities of daily living or results in 3rd party procedural consent being obtained
- •ASA physical status grade 4-5
研究组 & 干预措施
"light" sedation
In this study the depth of sedation will be guided by the Bispectral Index monitor (BIS monitor). A BIS value of 70-80 will be targeted in the "light" sedation arm.
干预措施: Sedation depth (Other)
"deep" sedation
In this study the "deep" sedation arm will have a BIS value of less than 60 targeted.
干预措施: Sedation depth (Other)
结局指标
主要结局
Recall of procedure
时间窗: 1 day. Day of procedure
Upon rousing patients will be asked if they remember anything between the commencement of sedation and when they awoke from sedation
次要结局
- Speed and quality of recovery(1 day. Day of procedure only. Measured before discharge from hospital)
- Satisfaction(1 day. Day of procedure only. Measured before discharge from hospital)
- Complications(1 day. Day of procedure only.)
- Dreaming(1 day. Day of procedure.)
研究者
Associate Professor Kate Leslie
Head of Reaseach and Staff anaesthetist, The Royal Melbourne Hospital
Melbourne Health