NCT02469831已完成2 期
The Impact of Deep Versus Moderate Neuromuscular Block on Respiratory System Mechanics and Metabolic Changes During Laparoscopic Cholecystectomy a Double-Blind Randomized Clinical Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- respiratory mechanics (Dynamic compliance)
研究概览
简要总结
The investigators aim to investigate the differences between deep continuous muscle relaxation and moderate blockade during low-pressure (8 mmHg) laparoscopic cholecystectomy in respect to metabolic changes and respiratory mechanics.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •more than 18 years
- •undergoing elective laparoscopic cholecystectomy
排除标准
- •previous surgeries,
- •a history of venous or arterial diseases,
- •BMI (≥30 kg/m2),
- •Allergy to rocuronium.
- •Significant liver dysfunction.
- •Significant renal dysfunction (S-creatinine > 200 umol/l).
- •Neuromuscular disease that might impair neuromuscular blockade
- •Pregnant or breastfeeding.
- •Indication for rapid sequence induction.
- •Inability to informed consent
研究组 & 干预措施
group D
Active Comparator
deep neuromuscular block by rocuronium defined :post tetanic (PTC) >1 but no response to a train of four (TOF) stimulation.
干预措施: Rocuronium (Drug)
group I
Active Comparator
intermediate neuromuscular block by rocuronium defined as TOF count of 1-3.
干预措施: Rocuronium (Drug)
结局指标
主要结局
respiratory mechanics (Dynamic compliance)
时间窗: intraoperative
Dynamic compliance
次要结局
- surgeon satisfaction (scale from 1 to 5)(intraoperative)
- postoperative nausea and vomiting(postoperative for 6 hours)
- metabolic changes (blood lactate)(intraoperative)
- postoperative pain (VAS score)(postoperative for 6 hours)
- completion of surgical procedure(intraoperative)
研究者
khaled salah mohamed
lecturer of anaesthesia and ICU
Assiut University
研究点 (1)
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