| CTRI Number |
CTRI/2025/08/093293 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
COMPARING THE EFFECTS OF MAGNESIUM SULPHATE OR DEXAMETHASONE FOR POSTOPERATIVE ANALGESIA IN ADULT PATIENTS FOR LAPAROSCOPIC CHOLECYSTECTOMY |
|
Scientific Title of Study
|
COMPARING THE EFFECTS OF MAGNESIUM SULPHATE OR DEXAMETHASONE FOR POSTOPERATIVE ANALGESIA IN ADULT PATIENTS FOR 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 PRASHANTH PRABHU J |
| Designation |
PROFESSOR |
| Affiliation |
sapthagiri institue of medical sciences |
| Address |
SAPTHAGIRI INSTITUE OF MEDICAL SCIENCES BENGALURU
sims and rc bengaluru
Bangalore
KARNATAKA
560090
India |
| Phone |
9035067161 |
| Fax |
|
| Email |
prashanthjnpl@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PRASHANTH PRABHU J |
| Designation |
PROFESSOR |
| Affiliation |
sapthagiri institue of medical sciences |
| Address |
SAPTHAGIRI INSTITUE OF MEDICAL SCIENCES BENGALURU
sims and rc bengaluru
Bangalore
KARNATAKA
560090
India |
| Phone |
9035067161 |
| Fax |
|
| Email |
prashanthjnpl@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRASHANTH PRABHU J |
| Designation |
PROFESSOR |
| Affiliation |
sapthagiri institue of medical sciences |
| Address |
SAPTHAGIRI INSTITUE OF MEDICAL SCIENCES BENGALURU
sims and rc bengaluru
Bangalore
KARNATAKA
560090
India |
| Phone |
9035067161 |
| Fax |
|
| Email |
prashanthjnpl@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
sapthagiri institue of medical sceinces bengaluru |
| Address |
sims and rc bengaluru |
| 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 |
| Dr Akshay Rathod |
Sapthagiri institute of medical sciences and hospital bangalore |
Sapthagiri institute of medical sciences bangalore
15, hesarghatta rd, navy layout,ABG layout, chikkabanavara Bengaluru Karnataka 560090
Bangalore
KARNATAKA |
8088461710
akshayrathod9535@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sapthagiri institute of medical sciences, sapthagiri NPS university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patient posted for laparoscopic cholecystectomy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DR AKSHAY RATHOD |
Postgraduate
Department of anaesthesia sims and rc,15, hesarghatta rd, navy layout,ABG layout, chikkabanavara Bengaluru Karnataka 560090 |
| Intervention |
Dr Prashanth prabhu j |
Professor, department of anaesthesia sims and rc ,15 , hesarghatta rd, navy layout,ABG layout chikkabanavara Bengaluru Karnataka 560090 |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
asa grade 1 and 2
bmi 18-28 kg/m2
all patients posted for laparoscopic cholecystectomy
|
|
| ExclusionCriteria |
| Details |
on sedatives/hypnotics preoperatively
pyschiatric illness/ alcohol abuse
patient with known history to allergy to study drug
pregnant and lactating mothers
surgery duration more than 3 hours |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the analgesic effects of intravenous magnesium sulphate and intravenous dexamethasone in adult patients for laparoscopic cholecystectomy by NRS scoring for first 24 hours of postoperative |
to compare the analgesic effects of intravenous magnesium sulphate and intravenous dexamethasone in adult patients for laparoscopic cholecystectomy by NRS scoring for first 24 hours of postoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the hemodynamic responses intraoperatively with intravenous magnesium sulphate and intravenous dexamethasone |
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 1 |
|
Date of First Enrollment (India)
|
30/08/2025 |
| 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="0"
Months="4"
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
|
comparing the effects of magnesium sulphate or dexamethasone for postoperative analgesia in adult patients for laparoscopic cholecystectomy by NRS system for 24 hours |