Low pressure pneumoperitoneum versus standard pressure pneumoperitoneum in patient undergoing laparoscopic cholecystectomy with deep neuromuscular blockade: a randomized non inferiority control trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Quality of surgical field, assessed using a Leiden surgical rating scale
研究概览
简要总结
Laparoscopic cholecystectomy is the standard treatment for gallstone. It typically involved creating a pneumoperitoneum , most commonly at standard pressure of 12 to 15 mug to improve visualisation and working space. However, higher pressure associated with adverse effect such as shoulder pain, cardiovascular and respiratory issues. Recent studies suggest that low pressure pneumoperitoneum (7-10 mmhg) when combined with deep neuromuscular blockade may reduce these complication while maintaining adequate surgical field conditions. While low pressure pneumoperitoneum may reduce perioperative morbidity, there are concerns with relations to the standard of the surgical field and procedure duration. Deep NMB can potentially counteract these issues by providing better muscle relaxation. This study aims to evaluate if low pressure pneumoperitoneum with deep neuromuscular blockade is non inferior to standard pressure pneumoperitoneum in terms of surgical field quality while offering benifits in reducing post operative pain and comlocations
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Patient aged 18 or above with ASA grade 1 or 2 undergoing laparoscopic cholecystestomy.
排除标准
- •Emergency surgery or history of upper abdominal surgery or BMI more than thirty five or Patient having NMD or drug allergy or Intra operative duration more than hundred minutes or difficult laparoscopic cholecystectomy based on pre operative clinical assessment.
结局指标
主要结局
Quality of surgical field, assessed using a Leiden surgical rating scale
时间窗: Intraoperative assessment
次要结局
- Postoperative pain measured by VAS score(Postoperative complication ( shoulder pain ,nausea ,vomiting, cardiovascular symptoms, respiratory symptoms)
研究者
Dr Birender Kumar Yadav
AIIMS Bhubaneswar
