| CTRI Number |
CTRI/2025/09/094105 [Registered on: 02/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparison Between magnesium sulphate and ketamine as analgesia in adult patients for laparoscopic cholecystectomy in a tertiary care center double blind randomized controlled study |
|
Scientific Title of Study
|
A comparative study Between magnesium sulphate and ketamine as analgesic in adult patients for laparoscopic cholecystectomy in a tertiary care center double blind randomized controlled study |
| 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 bengaluru |
| Address |
department of anaesthesia ,gound floor sapthagiri hospital,sims and rc, 15, Hesarghatta Rd, Navy Layout, AGB layout, Chikkabanavara, Bengaluru, Karnataka 560090
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 bengaluru |
| Address |
department of anaesthesia ,gound floor sapthagiri hospital,sims and rc, 15, Hesarghatta Rd, Navy Layout, AGB layout, Chikkabanavara, Bengaluru, Karnataka 560090
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 bengaluru |
| Address |
department of anaesthesia ,gound floor sapthagiri hospital,sims and rc, 15, Hesarghatta Rd, Navy Layout, AGB layout, Chikkabanavara, Bengaluru, Karnataka 560090
Bangalore
KARNATAKA
560090
India |
| Phone |
9035067161 |
| Fax |
|
| Email |
prashanthjnpl@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saptagiri hospital,Saptagiri institute of medical sciences 15, Hesarghatta Rd, Navy Layout, AGB layout, Chikkabanavara, Bengaluru, Karnataka 560090
India |
|
|
Primary Sponsor
|
| Name |
sapthagiri institue of medical sceinces bengaluru |
| Address |
department of anaesthesia ,ground floor,Sapthagiri Institute of Medical Sciences and Research Centre 15, Hesarghatta Rd, Navy Layout, AGB layout, Chikkabanavara, Bengaluru, Karnataka 560090 |
| 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 hospital ,Sapthagiri Institute of Medical Sciences and Research Centre |
Department of anaesthesia ,ground floor sapthagiri hospital,15, Hesarghatta Rd, Navy Layout, AGB 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 |
| Saptagiri institute of medical sciences and research centre, Saptagiri nps university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy volunteers posted for laparoscopic cholecystectomy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ketamine |
0.5mg/kg iv bolus for 5 minutes before intubation and 0.25mg/kg/hr iv infusion during surgery |
| Intervention |
Magnesium sulphate |
1gm as iv bolus over 5min before intubation and 0.5 gm/hr as in infusion during surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2
BMI 18-28 kg/m2
all patients posted for laparoscopic cholecyestectomy |
|
| ExclusionCriteria |
| Details |
on sedatives/hypnoticspreoperatively
psychiatric 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
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the analgesic effects of intravenous magnesium sulphate and inravenous ketamine in adult patients for laparoscopic cholecystectomy by NRS scoring postoperatively |
To access pain by NRS scoring system postoperatively for first 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the hemodynamic responsesintraoperatively with intravenous magnesium sulphate and inravenous ketamine |
intraoperatively hemodynamic response with study drug and surgery procedure less than 3 hours |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/09/2025 |
| 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="6"
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
|
it is a double blind randomized controlled study , comaparative between magnesium sulphate and ketamine as analgesic in adult patients for laparoscopic cholecystectomy , postoperatively to access pain by NRS scoring for first 24 hours of postoperative |