| CTRI Number |
CTRI/2026/04/107928 [Registered on: 09/04/2026] Trial Registered Prospectively |
| Last Modified On: |
08/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing Two Doses of Magnesium Sulphate to Control Blood Pressure During Laparoscopic Gallbladder Surgery.
|
|
Scientific Title of Study
|
A Comparative Study of Two Doses of Magnesium Sulphate for Attenuation of Pneumoperitoneum-Induced Hemodynamic Changes during Laparoscopic Cholecystectomy |
| 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 Hemani Ahuja |
| Designation |
Professor |
| Affiliation |
Christian Medical College and Hospital ludhiana |
| Address |
Department of Anaesthesia and Critical Care
Christian Medical College Ludhiana
Punjab India
Department of Anaesthesia and Critical Care
Christian Medical College and Hospital
Ludhiana ,Punjab ,India
Ludhiana
PUNJAB
141008
India |
| Phone |
9501004338 |
| Fax |
|
| Email |
Hemaniahuja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mehrab Gill |
| Designation |
PG Resident |
| Affiliation |
Christian Medical College and Hospital ludhiana |
| Address |
Department of Anaesthesia and Critical Care
Christian Medical College Ludhiana
Punjab India
Department of Anaesthesia and Critical Care
Christian Medical College and Hospital
Ludhiana ,Punjab ,India
Ludhiana
PUNJAB
141008
India |
| Phone |
9888469906 |
| Fax |
|
| Email |
mehrabgill19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemani Ahuja |
| Designation |
Professor |
| Affiliation |
Christian Medical College and Hospital ludhiana |
| Address |
Department of Anaesthesia and Critical Care
Christian Medical College Ludhiana
Punjab India
Department of Anaesthesia and Critical Care
Christian Medical College and Hospital
Ludhiana ,Punjab ,India
Ludhiana
PUNJAB
141008
India |
| Phone |
9501004338 |
| Fax |
|
| Email |
Hemaniahuja@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Christian Medical College Ludhiana |
| Address |
Christina Medical college , Ludhiana ,141008
Punjab India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrHemani Ahuja |
Christian Medical College |
Department of Anaesthesia and critical Christian Medical College
ludhiana, Punjab , India
Ludhiana
PUNJAB |
9501004338
Hemaniahuja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) of Christian Medical College & Hospital, Ludhiana, Punjab, India. |
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: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
magnesium dose 1 |
30 mg/kg |
| Comparator Agent |
magnesium dose 2 |
50mg/kg |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 and ASA grade 2 |
|
| ExclusionCriteria |
| Details |
1.Known allergy to magnesium sulphate.
2.Severe renal dysfunction. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| attenuation of haemodynamic changes |
5 min,10 minutes,20 minutes,30 minutes,45 minutes,60 minutes,75 minutes,90 minutes,105 minutes,120 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bradycardia,hypotension.adverse effects like flushing,nausea |
itntra operatively & post operativley till 120 minutes |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 2 |
|
Date of First Enrollment (India)
|
20/04/2026 |
| 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="6"
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
|
This study aims to compare the efficacy of two doses of intravenous magnesium sulfate in attenuating hemodynamic changes during laparoscopic cholecystectomy Adult patients undergoing elective laparoscopic cholecystectomy will be randomized to receive either dose A or dose B of magnesium sulfate before induction of anesthesia The study is a randomized double blind parallel arm trial The primary outcome is the change in mean arterial pressure and heart rate during pneumoperitoneum Secondary outcomes include incidence of hypotension bradycardia requirement of rescue medications and adverse effects of magnesium sulfate |