Warmed, Humidified Carbon Dioxide Insufflation vs Standard Carbon Dioxide in Laparoscopic Cholecystectomy: a Double-blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- Pain (Rated With a Visual Analog Scale for Pain)
研究概览
简要总结
The purpose of this study is to determine the effect of warmed, humidified carbon dioxide Insufflation vs standard carbon dioxide in laparoscopic cholecystectomy.
详细描述
Patients undergoing warmed, humidified carbon dioxide (CO2) insufflation for laparoscopic cholecystectomy will have less postoperative pain than patients undergoing laparoscopic cholecystectomy with standard CO2 insufflation. The study design is a double-blind, prospective, randomized study comparing patients undergoing laparoscopic cholecystectomy with standard CO2 insufflation vs those receiving warmed, humidified CO2. Main variables included postoperative pain (rated with a visual analog scales) and analgesic requirements.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of cholecystolithiasis
排除标准
- •Clinical diagnosis of cholecystolithiasis with cholecystitis
结局指标
主要结局
Pain (Rated With a Visual Analog Scale for Pain)
时间窗: first postoperative day
postoperative pain (rated with a visual analog scale for pain) and analgesic requirements at operation day. The visual analog scale for pain ranged from 0-10 (0 is no pain, 10 is Maximum of pain)
次要结局
- Core Temperature(during operation)
研究者
Klugsberger Bettina
Dr.med
Ludwig Boltzmann Institute for Operative Laparoscopy