| CTRI Number |
CTRI/2025/11/097236 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
10/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of different pressure laparoscopic cholecystectomy for gall stone disease in terms of post operative pain and inflammatory markers |
|
Scientific Title of Study
|
Comparison of inflammatory markers in low pressure pneumoperitoneum with deep neuromuscular block versus standard pressure pneumoperitoneum among patients undergoing laparoscopic cholecystectomy for gallstone disease: A Randomized Control Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankita Singh |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Delhi |
| Address |
Room 411, 4th floor,Department of Surgical Disciplines, Surgery Block, AIIMS, Delhi
Room 411, 4th floor,Department of Surgical Disciplines, Surgery Block, AIIMS, Delhi
New Delhi
DELHI
110029
India |
| Phone |
9968633853 |
| Fax |
|
| Email |
ankitasingh05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ankita Singh |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Delhi |
| Address |
Room 411, 4th floor,Department of Surgical Disciplines, Surgery Block, AIIMS, Delhi
Room 411, 4th floor,Department of Surgical Disciplines, Surgery Block, AIIMS, Delhi
New Delhi
DELHI
110029
India |
| Phone |
9968633853 |
| Fax |
|
| Email |
ankitasingh05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ankita Singh |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences, Delhi |
| Address |
Room 411, 4th floor,Department of Surgical Disciplines, Surgery Block, AIIMS, Delhi
Room 411, 4th floor,Department of Surgical Disciplines, Surgery Block, AIIMS, Delhi
New Delhi
DELHI
110029
India |
| Phone |
9968633853 |
| Fax |
|
| Email |
ankitasingh05@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intramural Research Grant from AIIMS, Ansari Nagar, Delhi-110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS Delhi |
| Address |
Ansari Nagar, Delhi -110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ankita Singh |
AIIMS,Delhi |
4th floor,Department of Surgical Disciplines, Surgery Block, AIIMS, Delhi
New Delhi
DELHI |
9968633853
ankitasingh05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Laparoscopic cholecystectomy under low pressure (8-10mm Hg) with deep neuro-muscular block (NMB) |
Cisatracurium infusion will be given at rate of 1-3 mcg/kg/min in order to maintain PTC at 1–2 in the deep NMB group. Neuromuscular monitoring will be done to ensure deep block throughout the surgery. One
side
arm and hand will be used for monitoring of NMB. Electrodes will be placed over the ulnar nerve
proximal to the wrist at a distance of 3–6 cm. Electrical stimulus will be applied to the ulnar nerve and
contractions of the adductor pollicis muscle will be measured through a sensor attached to the tip of the thumb. TOF will be monitored every 1 minute, and PTC every 3 min. ore temperature will be controlled at
36–37 °C. Cisatracurium infusion will be stopped once cystic artery and cystic duct are clipped and cut
to give adequate time for recovery from paralysis. Reversal will be achieved through neostigmine and
glycopyrrolate. |
| Comparator Agent |
Laparoscopic cholecystectomy under standard pressure (12- 14 mm Hg) with moderated NMB. |
Cisatracurium infusion will be given at rate of 1-3 mcg/kg/min in order to maintain TOF at 1–3 in the moderate NMB group. Rest of the monitoring will be same as in the intervention group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
BMI less than 30
ASA I,II
Patient able to follow instructions |
|
| ExclusionCriteria |
| Details |
Any prior inflammatory conditions like Arthritis, Chronic skin diseases, IBD
Pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in inflammatory marker levels between the 2 groups i.e. IL-6, IL-1,IL-17,TNF alpha, WBC, ESR, CRP,Albumin, cortisol, Hb, platelet count |
baseline, 24 hours post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain scores by NPRS
Incidence of Complications
Length of hospital stay
Conversion |
Pain scores by NPRS at 6, 24 hours
Incidence of Complications during surgery, upto 1 day post operatively
Length of hospital stay at discharge
Conversion during surgery |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
21/11/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
There is a dearth of literature regarding inflammatory markers in patients undergoing laparoscopic surgery with low-pressure pneumoperitoneum in combination with deep neuromuscular blockade. A few studies have explored the correlation between these markers and postoperative pain outcomes. Many patients still experience pain despite undergoing minimally invasive surgery. The utilization of objective markers can aid in understanding the reasons behind pain. Consequently, this study aims to compare the levels of inflammatory markers in patients undergoing laparoscopic cholecystectomy with low-pressure pneumoperitoneum and deep neuromuscular blockade (NMB) to those undergoing laparoscopic cholecystectomy using standard-pressure pneumoperitoneum with moderate NMB. |