The Effect of Deep Neuromuscular Blockade on Postoperative Shoulder Tip Pain After Laparoscopic Cholecystectomy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Shoulder tip pain
研究概览
简要总结
The purpose of this study was to investigate whether there is any difference in incidence of shoulder tip pain after laparoscopic cholecystectomy between the groups with moderate neuromuscular block and deep neuromuscular block.
详细描述
Laparoscopic cholecystectomy has become the gold standard treatment for gall bladder disease. However, 30-50% of patients suffer from shoulder tip pain, which might arise from diaphragm stretch due to pneumoperitoneum.
In the previous pilot study, working intra-abdominal space was increased in the condition of deep neuromuscular blockade. And thus investigators hypothesized that the depth of neuromuscular blockade can affect insufflation pressure and intra-abdominal volume, which result in the severity of diaphragm stretch and postoperative shoulder pain. In addition, the depth of neuromuscular blockade can alter pulmonary compliance.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •physical status by American society of Anesthesiology; 1 or 2 patients
- •patients with benign gallbladder disease scheduled for laparoscopic cholecystectomy
排除标准
- •patient with myasthenia gravis
- •allergy to rocuronium or sugammadex
- •patient with shoulder pain disease (Ex. rotator cuff tear)
- •psychological disease
- •patients who cannot understand Korean
研究组 & 干预措施
moderate NMB + standard pressure
Investigators will administrate rocuronium until moderate neuromuscular blockade (Train of Four >=1, Post-tetanic count>=8) is established. And pneumoperitoneum will be maintained with standard-pressure 14 mmHg.
干预措施: Rocuronium (Drug)
deep NMB + standard pressure
Investigators will administrate rocuronium until deep neuromuscular blockade (Train of Four=0, Post-tetanic count<=3) is established. And pneumoperitoneum will be maintained with standard-pressure 14 mmHg.
干预措施: Rocuronium (Drug)
deep NMB + low pressure
Investigators will administrate rocuronium until deep neuromuscular blockade (Train of Four=0, Post-tetanic count<=3) is established. And pneumoperitoneum will be maintained with standard-pressure 8 mmHg.
干预措施: Rocuronium (Drug)
结局指标
主要结局
Shoulder tip pain
时间窗: upto postoperative 24 hours
The severity of shoulder tip pain will be measured in PACU and upto postoperative 6, 6-12, 12-24 hours.
次要结局
- Satisfaction of the surgeon(upto postoperative 24 hours)
- Postoperative nausea and vomiting(upto postoperative 24hours)
- Postoperative pain(upto postoperative 24 hours)
- Working intrabdominal space(upto postoperative 24 hours)
- Intraoperative hemodynamics(upto postoperative 24hours)
- pulmonary compliance(upto postoperative 24 hours)