The Efficacy of Midazolam & Ketamine Versus Midazolam & Fentanyl for Sedation in Ambulatory Colonoscopies
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Recovery time
研究概览
简要总结
Providing adequate sedation and analgesia is an integral part of the practice of colonoscopy procedure.
There are various protocols and methods used to prevent discomfort and alleviate pain. Conscious sedation is one of the options recommended by the American Society for Gastrointestinal Endoscopy, although the choice of the exact protocol is left to the physician's discretion.
This study will attempt to recommend a preferred protocol based on a double blind randomized prospective method.
The efficacy of midazolam and ketamine will be compared to the efficacy of midazolam and fentanyl for sedation in ambulatory colonoscopies.
The results will be compiled from objective data and patient and physician interviews.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Candidates for elective colonoscopy at the Soroka Medical Center who have signed an informed consent.
排除标准
- •Hypersensitivity to benzodiazepines
- •Hypersensitivity to benzyl alcohol
- •Hypersensitivity to ketamine
- •Hypersensitivity to opiates
- •Uncontrolled hypertension
- •Myocardial infarct in the last 6 months
- •Chronic pulmonary disease
- •Renal failure
- •Chronic liver disease (CHILD B or C)
- •Elevated ICP, cerebral hemorrhage or cranial SOL.
- •Hypovolemic shock
- •Mental illness
- •Drug or alcohol addiction
研究组 & 干预措施
0
fentanyl
干预措施: Midazolam, Fentanyl (Drug)
1
ketamine
干预措施: KETAMINE, MIDAZOLAM (Drug)
结局指标
主要结局
Recovery time
时间窗: 24 hours following colonoscopy
次要结局
- Sedative effect(24 hours following colonoscopy)
- Patient compliance(24 hours following colonoscopy)
- Side effects(24 hours following colonoscopy)