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临床试验/CTRI/2024/12/077614
CTRI/2024/12/077614尚未招募4 期

Low pressure pneumoperitoneum versus standard pressure pneumoperitoneum in patient undergoing laparoscopic cholecystectomy with deep neuromuscular blockade: a randomized non inferiority control trial.

AIIMS Bhubaneswar1 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2024年12月10日最近更新:

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

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Birender Kumar Yadav

AIIMS Bhubaneswar

研究点 (1)

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