NCT00209885Unknown4 期
Optimal Multimodal Analgesia in Laparoscopic Cholecystectomy
适应症
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 1. postoperative abilities over time in PACU
研究概览
简要总结
To test the current standard of care (SOC) treatment for laparoscopic cholecystectomy with a group receiving SOC + additional perioperative analgesics in terms of postoperative abilities, PONV, pain and discharge time from the PACU
详细描述
Aim of the study: to compare postoperative complaints (PONV, pain, etc) and PACU discharge time between two groups:
- A: standard of care (SOC)receiving intraoperative dexamethasone, ondansetron, ketorolac, and general anaesthesia with propofol, remifentanil and cisatracurium
- B: SOC + preoperative gabapentin, intraoperative lidocain infusion, s-ketamin and droperidol.
Primary endpoints:
- postoperative abilities over time
- discharge time from PACU according to fixed criteria
- consumption of analgesics and antiemetics in the PACU
Secondary endpoints:
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
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
- •Elective laparoscopic cholecystectomy
- •Age above 18 years
- •Written informed consent
- •ASA class I-III
排除标准
- •Planned abdominal cholecystectomy
- •Intraoperative conversion of laparoscopic to laparotomic cholecystectomy
- •Allergy to part of the treatment regimens
- •Previous reactions to opioids (nausea, cognition)
结局指标
主要结局
1. postoperative abilities over time in PACU
2. discharge time from PACU according to fixed criteria
3. consumption of analgesics and antiemetics in the PACU
次要结局
- 1. Degree of nursing requirements in the PACU
- 2. General tolerability of the regimens
研究者
研究点 (2)
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