NCT03171610已完成不适用
Randomized Double-blind Study on Efficacy of iv PCA With Fentanyl or Sufentanil in Patients Undergoing Laparoscopic Nephrectomy
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
- 82
- 试验地点
- 1
- 主要终点
- Efficacy of iv PCA with fentanyl or sufentanil in patients undergoing laparoscopic nephrectomy: Incidence of postoperative nausea and vomiting (PONV)
研究概览
简要总结
The purpose of this study is to compare the efficacy of iv PCA with fentanyl or sufentanil in patients undergoing laparoscopic nephrectomy
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing laparoscopic or robot-assisted laparoscopic nephrectomy (total or partial)
- •patient who want intravenous PCA for postoperative pain control
排除标准
- •long-term use of opioid, pain reliever or tranquilizers
- •a history of DM neuritis
- •prolonged prothrombin time or activated partial thromboplastin time
- •impairment of cognitive function
- •obesity (BMI ≥ BMI 30 kg/m2)
研究组 & 干预措施
Fentanyl group
Active Comparator
PCA with fentanyl (20 mcg/kg), ramosetron (NaseaTM) 0.3 mg and ketorolac 120 mg in a normal saline with a total volume of 100ml
干预措施: Fentanyl group (Drug)
Sufentanil group
Experimental
Arm Description: PCA with sufentanil (3 mcg/kg), ramosetron (NaseaTM) 0.3 mg and ketorolac 120 mg in a normal saline with a total volume of 100ml
干预措施: Sufentanil group (Drug)
结局指标
主要结局
Efficacy of iv PCA with fentanyl or sufentanil in patients undergoing laparoscopic nephrectomy: Incidence of postoperative nausea and vomiting (PONV)
时间窗: 24 hrs after recovery room discharge
Incidence of postoperative nausea and vomiting (PONV)
次要结局
- postoperative pain score(at arrival to recovery room, 30 minutes after arrival to recovery room, 1 hour after recovery room discharge, 6 hrs after recovery room discharge, 24 hrs after recovery room discharge)
研究者
研究点 (1)
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