A Randomized Study of Midazolam and Fentanyl Versus Midazolam Alone for Sedation in Gastrointestinal Endoscopy
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Pain Felt During the Procedure
研究概览
简要总结
This is a noninferiority study designed to examine whether conscious sedation with midazolam alone results in efficacy and safety that is not inferior to the combination of midazolam and fentanyl. English-speaking patients ≥18 years old and ≤75 years old presenting for GI endoscopy planned with conscious sedation using midazolam and fentanyl, will be randomized 1:1 to single agent sedation with midazolam or combination sedation with midazolam and fentanyl. Participants will be blinded to the choice of sedation. Sedation quality and adverse events will be measured with a validated patient-centered measure of procedural sedation quality, the PROcedural Sedation Assessment Survey (PROSAS) [Leffler, et al. Gastrointest Endosc. 2015;81(1):194-203]. Endoscopic quality measures in the 2 study groups will be collected by retrospective chart review, as an additional metric to ensure the quality of the procedure is not compromised by the choice of sedation.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English-speaking patients
- •Patients ≥18 years old and ≤75 years old
- •Outpatients presenting for EGD and/or colonoscopy planned with conscious sedation using midazolam and fentanyl
- •Patients presenting for endoscopic procedures with no GI fellow or trainee involvement in the procedure
排除标准
- •Patients with an allergy or prior adverse event to either fentanyl or midazolam
- •Patients who have previously not tolerated endoscopy with conscious sedation and require monitored anesthesia care (MAC)
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Prisoners
- •Vulnerable populations, including cognitively impaired adults and adults who are otherwise unable to consent
研究组 & 干预措施
midazolam alone
Patients in this arm will receive conscious sedation with medazepam alone
干预措施: midazolam alone (Drug)
结局指标
主要结局
Pain Felt During the Procedure
时间窗: 1 day
Level of discomfort during the procedure as assessed by the previously validated PROcedural Sedation Assessment Survey (PROSAS) questionnaire \[Leffler, et al. Gastrointest Endosc. 2015;81(1):194-203\]. The patient will answer the question "How much discomfort did you experience during the procedure?" A visual analog scale will be used ranging from 0 to 10 with higher numbers indicating more pain.
Adequacy of Sedation
时间窗: 1 day
Adequacy of sedation as assessed by the previously validated PROcedural Sedation Assessment Survey (PROSAS) questionnaire \[Leffler, et al. Gastrointest Endosc. 2015;81(1):194-203\]. The patient will answer the question "If having this procedure again in the future, how much sedation would you prefer to have?" A visual analog scale will be used ranging from -5 to 5, with lower numbers indicating a preference for less sedation in the future and higher numbers indicating a preference for more sedation in the future.
次要结局
- Patient Reported Nausea(1 day)
- Adverse Events(1 day)
- Cecal Intubation Rate(through study completion, an average of 1 year)
- Cecal Intubation Time(through study completion, an average of 1 year)
- Adenoma Detection Rate(through study completion, an average of 1 year)
- Colonoscopy Withdrawal Time(through study completion, an average of 1 year)
研究者
Greg Cohen
Clinical Associate Professor of Medicine
Greg S Cohen MD LLC