| CTRI Number |
CTRI/2025/07/091644 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the pain relieving effects of magnesium sulphate and paracetamol after surgery |
|
Scientific Title of Study
|
To compare the efficacy intravenous magnesium sulphate and paracetamol for post- operative analgesia on adult patients undergoing laparoscopic cholecystectomy- Randomized controlled 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 |
Venkatesh Prasad S |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru medical college, Aligarh Muslim University, Aligarh |
| Address |
Department of anesthesiology and critical care , jawaharlal nehru medical college, aligarh muslim university, aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9791180563 |
| Fax |
|
| Email |
venkatsgoods@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syed Hussain Amir |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru medical college, Aligarh Muslim University, Aligarh |
| Address |
Department of anesthesiology and critical care, jawaharlal Nehru medical college, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897559183 |
| Fax |
|
| Email |
hussainamir77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Venkatesh Prasad S |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru medical college, Aligarh Muslim University, Aligarh |
| Address |
Department of anesthesiology and critical care, jawaharlal Nehru medical college, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9791180563 |
| Fax |
|
| Email |
venkatsgoods@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesiology and critical care, jawaharlal nehru medical college, Aligarh Muslim University, Aligarh |
|
|
Primary Sponsor
|
| Name |
Department of anesthesiology and critical care, jawaharlal nehru medical college, AMU |
| Address |
Department of anesthesiology and critical care, jawaharlal nehru medical college, Aligarh Muslim University, Aligarh |
| Type of Sponsor |
Government 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 |
| Venkatesh Prasad S |
Jawaharlal Nehru medical college and hospital |
Department of anesthesiology and critical care, jawaharlal nehru medical college, Aligarh
Aligarh
UTTAR PRADESH |
9791180563
venkatsgoods@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K808||Other cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Magnesium sulphate and paracetamol for post- opertive analgesia |
For post- opertive analgesia using intravenous magnesium sulphate and paracetamol on adult laproscopic cholecystectomy patients |
| Comparator Agent |
Magnesium sulphate and paracetamol for post- opertive analgesia |
Intravenous magnesium sulphate and paracetamol for post-opertive analgesia in adult patients |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Weight between 30 - 70 kg
Patients planned for Elective laproscopic cholecystectomy surgeries |
|
| ExclusionCriteria |
| Details |
Patients with history of allergic to analgesics.
Patients with history of smoking.
Patients who received analgesics drugs within 24 hours before surgery
Patients with history of myasthenia gravis, diabetic mellitus, pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of magnesium sulphate versus paracetamol |
Both the groups will be assessed prior to injection and towards the end of the surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Study the complications of drugs used.
Evaluate the requirement of analgesics drugs in first 24 hours
|
Pain score after surgery
Patients satisfaction score and complications of drugs administrated |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
04/08/2025 |
| 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
|
This study aims to compare the efficacy of magnesium sulphate and paracetamol for post-opertive analgesia in adult patients undergoing laproscopic cholecystectomy. After the surgery most commonly patients will complaints of pain to reduce these complications will give analgesics to the patient’s. Intravenous magnesium sulphate and paracetamol towards the end of surgery will give to the different groups of patients and pain levels will be assessed. To determine which agent provides better pain control and reduces the need for additional analgesics in the post-opertive period. |