Effect of low pressure pneumoperitoneum with deep neuromuscular block in patients undergoing laparoscopic cholecystectomy.
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2021/08/035975
- Lead Sponsor
- All India Institute of Medical Sciences New Delhi
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 224
- 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.
- 1.Age > 65 or <18 2.BMI > 35 3.Unable to give consent or patient refusal.
- 4.Unfit for general anaesthesia.
- 5.Pregnancy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Ease of operation according to predefined surgical rating scale. At completion of surgery. 2.Time taken for completion of procedure At completion of surgery.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
All India Institute Of Medical Sciences New Delhi
🇮🇳Delhi, DELHI, India
All India Institute Of Medical Sciences New Delhi🇮🇳Delhi, DELHI, IndiaPrasanna Ramana APrincipal investigator9742712903prasannaramana326@gmail.com