Use of Diphenhydramine as an Adjunctive Sedative for Colonoscopy in Patients Chronically on Opioids
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Dosage of Fentanyl
研究概览
简要总结
To access the efficacy of adding diphenhydramine as adjunct to improve sedation and to reduce the amount of standard sedatives used during colonoscopy in patients on chronic opioids.
详细描述
Specific Aims:
The primary aim of our study is to determine if addition of Diphenhydramine to Fentanyl and Midazolam will decrease the dose of Fentanyl and Midazolam used during colonoscopy in individuals on chronic opioids. Secondarily we will be looking at quality of sedation, duration of colonoscopy, time to reach cecum and adverse effects (hypoxia defined as O2 saturation less than 89% lasting for more than 30 seconds, hypotension defined as systolic BP less than 90 mmhg and use of reversal agents i.e Naloxone or Flumazenil).
Day of Procedure:
After consent is obtained the medical records of the patients will be reviewed and demographic information, co-morbidities, current medication will be extracted and recorded.
On the day of colonoscopy Alcohol use disorder inventory (AUDIT) will be used to screen for alcohol abuse. AUDIT was developed by World Health Organization and has been validated over a period of 2 decades. It consist of 10 questions, each question is scored 0-4 on the basis of subjects alcohol use. It takes about 2-4 minutes to complete. A score 10 or greater is highly specific or alcohol use.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-64 years undergoing screening, surveillance, diagnostic and therapeutic colonoscopy
- •Patient on chronic opioids defined as at least 5 mg of morphine or its equivalent at least 3 days per week for more than 3 months
排除标准
- •Inability to execute informed consent
- •Allergy to Diphenhydramine, fentanyl or midazolam
- •Known or suspected pregnancy
- •Endoscopic procedure without sedation
- •Patient scheduled to have other endoscopic procedures on the same day
- •Prior alimentary tract surgery
- •Severe cardiopulmonary disease (ASA IV)
- •Monoamine Oxidase Inhibitors (MOI) use within 2 weeks of procedure
研究组 & 干预措施
Diphenhydramine
Diphenhydramine 50 mg IV 3 minutes prior to administration of other sedatives
干预措施: Diphenhydramine (Drug)
Placebo
0.9% sodium chloride 10 ml IV 3 minuted prior to administration of other sedatives
干预措施: Placebo (Drug)
结局指标
主要结局
Dosage of Fentanyl
时间窗: From induction (first dose of sedative) to end of procedure
Moderate sedation (using the American Society of Anesthesiologists definition of maintaining purposeful response to verbal or tactile stimulation, adequate ventilation requiring no airway protection, and maintenance of cardiovascular function) was then achieved using incremental doses of the combination of intravenous midazolam (1 mg) and fentanyl (25 μg) given every 2 to 3 minutes. To minimize any crossover, additional diphenhydramine was not permitted.
次要结局
- Quality of Sedation(During the colonoscopy and 24 hours after discharge)
- Number of Participants With Adverse Events(From induction (first dose of sedative) to discharge)
- Duration of Procedure(Time from induction (first dose of sedative) to discharge)
- Dosage of Midazolam(From induction (first dose of sedative) to end of procedure)
- 24 Hour Follow up Amnesia Score(At about 24 after the procedure)
- 24 Hour Follow up Pain Score(About 24 hours after the procedure)