NCT02543411已完成不适用
Effect of Intravenous Lidocaine During Endoscopic Submucosal Dissection for Gastric Neoplasm
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Fentanyl consumption during sedation
研究概览
简要总结
The primary purpose of this study is to investigate the effects of lidocaine on the total administered dose of fentanyl during sedation for endoscopic mucosal resection.
The secondary purpose of this study is to investigate the effects of lidocaine on pain score related with endoscopic mucosal resection at time of 30 min, 6 hr, and 24 hr after procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Endoscopic submucosal dissection for the treatments of early gastric neoplasm
排除标准
- •Allergy to lidocaine
- •Chronic pain
- •Chronic abuse of opioid or NSAID
- •Atrioventricular conductance block
- •Liver dysfunction
- •Renal dysfunction
研究组 & 干预措施
Lidocaine group
Experimental
Administration of lidocaine 1%
干预措施: Lidocaine 1% (Drug)
Control group
Placebo Comparator
Administration of normal saline
干预措施: Normal saline (Drug)
结局指标
主要结局
Fentanyl consumption during sedation
时间窗: During sedation, an expected average of 40 minutes
次要结局
- Pain intensity measured by numerical rating scale(30 min, 6 hr, and 24 hr after procedure)
- Incidence of nausea and vomiting(Up to 24 hours)
研究者
So Yeon Kim
Assistant professor
Severance Hospital
研究点 (1)
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