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临床试验/CTRI/2021/08/035975
CTRI/2021/08/035975尚未招募不适用

To study the outcomes of low pressure pneumoperitoneum with deep neuromuscular block versus standard pressure pneumoperitoneum in patients undergoing laparoscopic cholecystectomy for gallstone disease: A Randomized Control Trial.

All India Institute of Medical Sciences New Delhi1 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2021年1月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
224
试验地点
1
主要终点
1.Ease of operation according to predefined surgical rating scale.

研究概览

简要总结

Traditionally 12 to 14 mmHg is used for pneumoperitoneum in laparoscopic surgery including cholecystectomy. This pressure has adverse physiological effects like decreased cardiac return, decreased GFR, increased ventilatory pressures, and postoperative pain. Low-pressure pneumoperitoneum has been used to ameliorate the effects. However,  there is the issue of unfavorable working space. To solve this aspect the use of deep neuromuscular blockade has gained interest. In this study patients undergoing laparoscopic cholecystectomy will be randomized into low-pressure pneumoperitoneum with deep neuromuscular block group and the standard pressure pneumoperitoneum group. Primarily the ease of operation will be assessed using a predefined surgical rating scale based on a Likert scale of 1 to 5. The duration taken to complete the procedure will be recorded in both groups. Secondary outcomes like pain scores, conversion rate, time for extubation, and complications will also be assessed.

This study will be conducted as a prospective non-inferiority randomized control trial. The null hypothesis is that low-pressure pneumoperitoneum with deep neuromuscular block is inferior to standard pressure pneumoperitoneum in terms of ease of operation and duration for completion of surgery. Rejection of the null hypothesis will establish non-inferiority.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.All patients undergoing laparoscopic cholecystectomy.
  • 2.BMI≤35 3.18 to 65 years of age both male and female.
  • 4.Patient is able to follow instructions.
  • 5.Able to provide informed written consent.

排除标准

  • 1.Age > 65 or <18 2.BMI > 35 3.Unable to give consent or patient refusal.
  • 4.Unfit for general anaesthesia.
  • 5.Pregnancy.

结局指标

主要结局

1.Ease of operation according to predefined surgical rating scale.

时间窗: At completion of surgery.

2.Time taken for completion of procedure

时间窗: At completion of surgery.

次要结局

  • 1.Pain score at 1hr, 6 hr, 24 hr and 7 days after operation.(2.Conversion rates from low to standard pressure and to open.)

研究者

发起方
All India Institute of Medical Sciences New Delhi
申办方类型
Government medical college

研究点 (1)

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