Meperidine as the Single Sedative Agent for Patients Expected to Have Poor Tolerance During Diagnostic Esophagogastroduodenoscopy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- discomfort score during esophageal intubation
研究概览
简要总结
Our pilot results showed that meperidine reduce patient discomfort during EGD (esophagogastroduodenoscopy). But many patients can tolerate EGD well without any sedative agents. So the investigators target the use of meperidine on patients expected to have poor tolerance in this study, which includ young females with high anxiety level and patients with prior poor tolerance. The investigators test the hypothesis that meperidine improves tolerance and alleviates discomfort for patients expected to have poor tolerance during diagnostic EGD.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •female youger than 65 years with high anxiety level
- •patients with previous poor tolerance of EGD
排除标准
- •a therapeutic EGD
- •sedation with other agents
- •contraindication to Buscopan (hyoscine N-butylbromide) or meperidine
- •American Society of Anesthesiology (ASA) risk Class 3 or higher, renal failure
- •age less than 20 years or more than 80 years
- •pregnancy
- •refusal to provide written informed consent. All participants signed written informed consents
研究组 & 干预措施
placebo
1 ml normal saline will be given 5 minutes before EGD
干预措施: placebo (Drug)
meperidine
25 mg intramuscular meperidine will be given 5 minutes before EGD
干预措施: Meperidine (Drug)
结局指标
主要结局
discomfort score during esophageal intubation
时间窗: 10 minutes
self-reported discomfort score during esophageal intubation, assessed with a 0 to 10 (0 = none; 10 = unbearable) visual analog scale (VAS).
次要结局
- patient tolerance score evaluated by the endoscopist(10 minutes)
- patients satisfaction score(10 minutes)
- patient discomfort score during the procedure(10 minutes)
- endoscopist satisfaction score(10 minutes)
研究者
Yu-Hsi hsieh
Chief of Gastroenterology Endoscopy Suite
Dalin Tzu Chi General Hospital