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CTRI Number  CTRI/2021/08/035975 [Registered on: 26/08/2021] Trial Registered Prospectively
Last Modified On: 06/08/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of low pressure pneumoperitoneum with deep neuromuscular block in patients undergoing laparoscopic cholecystectomy. 
Scientific Title of Study   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. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prasanna Ramana Arumugaswamy 
Designation  Senior Resident 
Affiliation  AIIMS, NEW DELHI 
Address  Department of Surgical Disciplines, AIIMS, New Delhi 110029
Department of Surgical Disciplines, AIIMS, New Delhi 110029
New Delhi
DELHI
110029
India 
Phone  9742712903  
Fax    
Email  prasannaramana326@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Sunil Chumber 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Head of department Dept of Surgical Disciplines All India Institute of Medical Sciences, New Delhi - 110029
Head of department Dept of Surgical Disciplines All India Institute of Medical Sciences, New Delhi - 110029
New Delhi
DELHI
110029
India 
Phone  9871060404  
Fax    
Email  sunil_chumber@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr Sunil Chumber 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Head of department Dept of Surgical Disciplines All India Institute of Medical Sciences, New Delhi - 110029
Head of department Dept of Surgical Disciplines All India Institute of Medical Sciences, New Delhi - 110029
New Delhi
DELHI
110029
India 
Phone  9871060404  
Fax    
Email  sunil_chumber@hotmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences New Delhi 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences New Delhi 
Address  All India Institute Of Medical Sciences Ansari Nagar New Delhi 110029 India  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prasanna Ramana A  All India Institute Of Medical Sciences New Delhi  Dept of Surgical Disciplines, All India Institute Of Medical Sciences, Ansari Nagar, New Delhi 110029 India
New Delhi
DELHI 		 9742712903

prasannaramana326@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IECPG   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Low pressure pneumoperitoneum; 8 to 10mm Hg with Deep neuromuscular blockade.  Patients allocated to this group will undergo laparoscopic cholecystectomy with low pressure pneumoperitoneum of 8 to 10 mm Hg with deep neuromuscular block. Deep NMB is defined as 1 ≤ PTC ≤ 2. It will be achieved using cisatracurium infusion. Initial rate of cisatracurium infusion will be 0.1 mg/kg/h. The infusion rate will be adjusted in increments of 0.01 mg/kg/h in order to maintain PTC at 1–2  
Comparator Agent  standard pressure pneumoperitoneum; ≥ 12- 14 mm Hg with Moderate NMB  Patients allocated to this group will undergo laparoscopic cholecystectomy with standard pressure pneumoperitoneum of 12 to 14 mm Hg with routine moderate neuromuscular block. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  1. Age > 65 or <18
2. BMI > 35
3. Unable to give consent or patient refusal.
4. Unfit for general anaesthesia.
5. Pregnancy.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Ease of operation according to predefined surgical rating scale.
2. Time taken for completion of procedure
 		 At completion of surgery.
 
 
Secondary Outcome  
Outcome  TimePoints 
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.
3. Complications and other predefined parameters.
 		 At completion of surgery, 1 hour , 6 hour , 24 hour and 7 days. 
 
Target Sample Size   Total Sample Size="224"
Sample Size from India="224" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/09/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sunil_chumber@hotmail.com].

  6. For how long will this data be available start date provided 01-06-2024 and end date provided 01-06-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
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.
 
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