Fentanyl Use for Sedation in Esophagogastroduodenoscopy (FUSE): a Phase 4, Randomized, Double-blind, Placebo-controlled Trial of Fentanyl Added to Midazolam Compared to Midazolam Alone for Sedation in Routine Upper Endoscopy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Patient satisfaction with the level of sedation and comfort during the procedure on an analog scale
研究概览
简要总结
The purpose of this study is to determine whether conscious sedation with a narcotic and sedative (in combination) is as efficacious as a sedative alone for elective upper endoscopy to achieve optimal patient comfort and ease of procedure.
详细描述
Upper endoscopy is a valuable procedure that involves a camera advanced from the mouth into the intestines. It is a routine test and considered very safe. However, patients can experience discomfort from air insufflation in the stomach and unpleasantness due to gagging during the procedure. Conscious sedation with medications like sedatives and narcotics are used to improve patient satisfaction and enhance physician ability to perform an optimal examination. The choice of drugs used for sedation in upper endoscopy varies by endoscopist and the goal is always to use the lowest dose possible to achieve the best examination. Combination therapy (with a sedative & narcotic) may increase the adverse effect profile compared to a sedative alone and not improve the overall experience of the physician or patient. The goal of our study is to assess in randomized, double-blind, placebo controlled study, the effect of using a narcotic (fentanyl) and sedative (midazolam) for sedation compared to a sedative (midazolam) alone.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •outpatient elective upper endoscopy
- •age 18-65
- •able to give consent
排除标准
- •mental incompetency
- •pregnancy
- •weight <55kg or 110 lbs
- •emergent procedures,
- •known hypersensitivity or allergy to fentanyl or midazolam
- •chronic use of benzodiazepines or opioids
- •patients known a priori to require therapeutic interventions in conjunction with their EGD
- •patients to have major cardiorespiratory comorbidities, obstructive sleep apnea, liver cirrhosis, or renal failure
研究组 & 干预措施
Fentanyl
Fentanyl arm
干预措施: Midazolam (Drug)
Fentanyl
Fentanyl arm
干预措施: Fentanyl (Drug)
Placebo
Placebo of identical appearance
干预措施: Midazolam (Drug)
Placebo
Placebo of identical appearance
干预措施: Placebo (Other)
结局指标
主要结局
Patient satisfaction with the level of sedation and comfort during the procedure on an analog scale
时间窗: Within 72 hours of procedure
Level of satisfaction is obtained by telephone the following day, and up to 72 hours after the procedure.
次要结局
- Physician satisfaction with the level of sedation and ease of procedure based on a visual analog scale(Following procedure up to time of discharge (average of 45 minutes after procedure started))
- Patient willingness to repeat procedure(Asked within 72 hours of procedure)
- Presence of significant retching(Following procedure up to time of discharge (average of 45 minutes after procedure started))
- Presence of adverse events(Following procedure up to time of discharge (average of 45 minutes after procedure started))
研究者
Khurram Khan
Assistant Professor of Medicine
St. Joseph's Healthcare Hamilton