| CTRI Number |
CTRI/2025/03/083408 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effect of carbon dioxide insufflation at different rates on hemodynamic parameters during laparoscopic surgery |
|
Scientific Title of Study
|
A randomised controlled trial to compare the effect of carbon dioxide insufflation at different rates on hemodynamic parameters during laparoscopic surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amit |
| Designation |
Post Graduate Student |
| Affiliation |
Maharaja Agrasen Medical College Agroha District Hisar |
| Address |
Department of Anaesthesia Maharaja Agrasen Medical College Agroha Hisar
Hisar
Haryana
125047
India
Hisar
HARYANA
125047
India |
| Phone |
9518472682 |
| Fax |
|
| Email |
amitvyas071995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANJEEV KUMAR |
| Designation |
Professor and Head |
| Affiliation |
Maharaja Agrasen Medical College Agroha District Hisar |
| Address |
Department of Anaesthesia Maharaja Agrasen Medical College Agroha Hisar Haryana 125047
Department of Anaesthesia Maharaja Agrasen Medical College Agroha Hisar Haryana 125047
Hisar
HARYANA
125047
India |
| Phone |
8059598861 |
| Fax |
|
| Email |
docsanjeevparmar77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjeev Kumar |
| Designation |
Professor and Head |
| Affiliation |
Maharaja Agrasen Medical College Agroha District Hisar |
| Address |
Department of Anaesthesia Maharaja Agrasen Medical Colllege Agroha Hisar
Hisar
Haryana
125047
India
Department of Anaesthesia Maharaja Agrasen Medical Colllege Agroha Hisar
Hisar
Haryana
125047
India
Hisar
HARYANA
125047
India |
| Phone |
8059598861 |
| Fax |
|
| Email |
docsanjeevparmar77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia
Maharaja Agrasen Medical College
Agroha Hisar Haryana India
125047 |
|
|
Primary Sponsor
|
| Name |
YOURSELF |
| Address |
Department of anaesthesia Maharaja Agrasen Medical College Agroha Hisar Haryana 125047 |
| Type of Sponsor |
Other [] |
|
|
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 Amit |
Maharaja Agrasen Medical College Agroha Hisar |
Department of Anaesthesia
1st floor
Hisar
HARYANA |
9518472682
amitvyas071995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharaja Agrasen Medical College Agroha Hisar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Carbon dioxide insufflation at different rates during laparoscopic surgery |
Compare the effect of different carbon dioxide insufflation at 1L/min, 3L/min and 5L/min on hemodynamic parameters during laparoscopic surgeries |
| Comparator Agent |
Compare the effect of carbon dioxide insufflation at different rates |
To find out whether low flow rate the carbon dioxide insufflation at 1L/min, 3L/min and 5L/min on hemodynamic parameters during laparoscopic surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. American Society of Anaesthesiologist (ASA) classification I-II.
2. 18-60 years old patients undergoing elective laparoscopic surgery willing to participate in study. |
|
| ExclusionCriteria |
| Details |
1. Patient refusal.
2. Patients for emergency laparoscopy.
3. Hypertensive patients.
4. Patients receiving sympathomimetic/sympatholytic medications |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Mean arterial pressure immediately after achieving target intra-abdominal pressure (T2).
2. Heart rate immediately after achieving target intra-abdominal pressure (T2). |
every 2 minutes upto 10 minutes after attainment of target pressure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Shoulder pain one hour post-operatively using Visual Analog Scale (VAS) score. |
The shoulder pain will be assessed using the Visual Analog Scale (VAS), with 0 being no pain and 10 being the worst possible pain, after 1 hour of completion of surgery |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 3 |
|
Date of First Enrollment (India)
|
08/04/2025 |
| 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="1"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The present study will be a randomized, double arm, parallel group triple blind active controlled trial and will be conducted at Department of Anesthesiology and Critical care at Maharaja Agrasen Medical College, Agroha after approval from institutional ethical committee.
To estimate Mean arterial pressure immediately after achieving target intra-abdominal pressure (T2). To estimate Heart rate immediately after achieving target intra-abdominal pressure (T2).
Secondary objective of the study will be- To assess Shoulder pain one hour post-operatively using Visual Analog Scale (VAS) score |