Meperidine as the Single Sedative Agent During Esophagogastroduodenoscopy, a Double-blind, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- discomfort score during esophageal intubation
研究概览
简要总结
Upper endoscopy is uncomfortable for most patients. Meperidine has both sedative and analgesic effects, so its use may be helpful for patients receiving upper endoscopy.
详细描述
Unsedated esophagogastroduodenoscopy (EGD) is a useful tool for upper gastrointestinal tract examination and therapy, but it is uncomfortable for many patients. Meperidine has been widely used in colonoscopic examination for many years; however, its use in EGD has not been completely evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing diagnostic upper endoscopy in our endoscopic room were enrolled.
排除标准
- •A therapeutic upper endoscopic procedure, sedated endoscopy, contraindication to Buscopan (hyoscine N-butylbromide)
- •Allergy to meperidine
- •American Society of Anesthesiology (ASA) risk Class 3 or higher
- •Renal failure
- •Decompensated cirrhosis
- •Aged less than 20 years or more than 65 years
- •Pregnancy
- •Refusal to provide written informed consent.
研究组 & 干预措施
meperidine
25 mg of meperidine is injected intramuscularly before EGD
干预措施: Meperidine (Drug)
placebo
placebo was given intramuscularly before EGD
干预措施: normal saline (Drug)
结局指标
主要结局
discomfort score during esophageal intubation
时间窗: 9 months
patient self-reported discomfort score during esophageal intubation, assessed with a 0 to 10 visual analog scale (VAS)
次要结局
- patient and endoscopist satisfaction score(9 months)
- patient tolerance of the procedure(9 months)
- endoscopist perception of patient tolerance ,(9 months)