| CTRI Number |
CTRI/2024/12/077614 [Registered on: 03/12/2024] Trial Registered Prospectively |
| Last Modified On: |
29/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of cholecystectomy outcomes with low pressure pneumoperitoneum and deep neuromuscular blockade |
|
Scientific Title of Study
|
Low pressure pneumoperitoneum versus standard pressure pneumoperitoneum in patient undergoing laparoscopic cholecystectomy with deep neuromuscular blockade: a randomized non inferiority control trial. |
| Trial Acronym |
COLD trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Birender Kumar Yadav |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of General surgery, AIIMS Bhubaneswar.
Khordha
ORISSA
751019
India |
| Phone |
9891236764 |
| Fax |
|
| Email |
birenderk783@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bikram Rout |
| Designation |
Associate Professor |
| Affiliation |
AIIMS BHUBANESWAR |
| Address |
Department of General surgery, AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
8763278543 |
| Fax |
|
| Email |
surg_bikram@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bikram Rout |
| Designation |
Associate Professor |
| Affiliation |
AIIMS BHUBANESWAR |
| Address |
Department of General surgery, AIIMS Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
8763278543 |
| Fax |
|
| Email |
surg_bikram@aiimsbhubaneswar.edu.in |
|
|
Source of Monetary or Material Support
|
| AIIMS Bhubaneswar, Partrapada, Khurdha - 751019, India |
|
|
Primary Sponsor
|
| Name |
AIIMS Bhubaneswar |
| Address |
Department of General Surgery AIIMS Bhubaneswar- 751019 |
| 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 Birender kumar yadav |
AIIMS |
Department of General Surgery AIIMS Bhubaneswar
Khordha
ORISSA |
9891236764
birenderk783@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE ,AIIMS BHUBANESWAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (3) ICD-10 Condition: K810||Acute cholecystitis, (4) ICD-10 Condition: K811||Chronic cholecystitis, (5) ICD-10 Condition: K812||Acute cholecystitis with chronic cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Low pressure pneumoperitoneum with deep neuromuscular blockade |
Surgery will be started with pneumoperitoneum of 8 mmhg with deep NMB with NMT monitoring and intra operative LSRS score will be calculated in every 20 minutes, if the score is poor then the pneumoperitoneum would be increase by 2 mmhg till the score become acceptable or the pneumoperitoneum pressure requirement become more than 12 mmhg or the surgery time more than 100 minutes. |
| Comparator Agent |
Standard pressure pneumoperitoneum with deep neuromuscular blockade |
Surgery will be done on standard pressure pneumoperitoneum with deep neuromuscular blockade. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patient aged 18 or above with ASA grade 1 or 2 undergoing laparoscopic cholecystestomy. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of surgical field, assessed using a Leiden surgical rating scale |
Intraoperative assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Postoperative pain measured by VAS score
Postoperative complication ( shoulder pain ,nausea ,vomiting, cardiovascular symptoms, respiratory symptoms
Recovery time
Duration of surgery |
Secondary outcomes will be asses till POD 2. |
|
|
Target Sample Size
|
Total Sample Size="172"
Sample Size from India="172"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/12/2024 |
| 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
|
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 |