CTRI Number |
CTRI/2021/01/030578 [Registered on: 19/01/2021] Trial Registered Prospectively |
Last Modified On: |
18/01/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Effect of intra peritoneal instillation of Magnesium sulfate on Post operative Analgesia in laparoscopic cholecystectomy. A Prospective Cohort study. |
Scientific Title of Study
|
POST OPERATIVE ANALGESIA IN LAPAROSCOPIC CHOLECYSTECTOMY FOLLOWING INTRA PERITONEAL MAGNESIUM SULFATE-AN OBSERVATIONAL STUDY |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DrJijo Jose |
Designation |
Junior resident |
Affiliation |
Government Medical College,Kozhikode |
Address |
Government Medical college
Department of Anaesthesiology
Kozhikode 673008 Government Medical College
Department of Anaesthesiology
Kozhikode-673008 Kozhikode KERALA 673008 India |
Phone |
9495591964 |
Fax |
|
Email |
jjose6391@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Rashmi Ravindran |
Designation |
Associate Professor |
Affiliation |
Government Medical College Kozhikode |
Address |
Government Medical College Kozhikode
Department of Anaesthesiology
Kozhikode Department of Anaesthesiology
Government Medical College
Kozhikode Kozhikode KERALA 673008 India |
Phone |
9061161811 |
Fax |
|
Email |
drrashmiarun@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Fijul Komu |
Designation |
Assistant Professor |
Affiliation |
Government Medical College Kozhikode |
Address |
Government Medical College Kozhikode
Department of Anaesthesiology Department of Anaesthesiology
Government Medical College
Kozhikode-673008 Kozhikode KERALA 673008 India |
Phone |
9895660004 |
Fax |
|
Email |
fij2007@gmail.com |
|
Source of Monetary or Material Support
|
Government Medical college,Kozhikode (material) |
|
Primary Sponsor
|
Name |
DrJijo Jose Government Medical CollegeKozhikode |
Address |
Government Medical College,Kozhikode
KERALAM -673008 |
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 |
DrJijo Jose Medical College HospitalGovernment Medical College Kozhikode |
Medical College Hospital Kozhikode ,Department of Anesthesiology. |
Government Medical College
Department of Anaesthesiology Kozhikode Kozhikode KERALA |
9495591964
jjose6391@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Instituitional Ethics Committee,Government Medical College Kozhikode |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: 3||Administration, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Intra peritoneal administration of Magnesium sulfate at the end of laparoscopic cholecystectomy for post operative pain relief. |
Magnesium sulfate 30mg/kg diluted with 30ml of normal saline which is instilled intra peritoneally at the end of laparoscopic cholecystectomy in group M, no magnesium sulfate is given intra peritoneally in group N |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1)Patients with American society of Anaesthesiologist class 1 or 2 undergoing elective cholecystectomy
2)BMI between 18 and 30 |
|
ExclusionCriteria |
Details |
1)Patients refusal
2)Pregnant and breast feeding
3)Patient on beta blocker
4)Patient with autonomic dysfunction
5)Patients with chronic pain on opioids and other analgesics
6)History of allergy to study drug |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Duration of analgesia,Mean pain scores during 1st 24 hours of post-operative period,Number of total doses of analgesics requirement at 24 hour and incidence of shoulder pain |
Duration of analgesia,Mean pain scores during 1st 24 hours of post-operative period,Number of total doses of analgesics requirement at 24 hour and incidence of shoulder pain |
|
Secondary Outcome
|
Outcome |
TimePoints |
Recovery profile,Post instillation hero dynamic changes in terms of heart rate ,systolic blood pressure,diastolic blood pressure,sedation,Post operative nausea and vomiting and respiratory depression if any |
Observed for first 24 hour of post operative period |
|
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
|
N/A |
Date of First Enrollment (India)
|
25/01/2021 |
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
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
It’s a study of post operative Analgesia in laparoscopic cholecystectomy following intra peritoneal instillation of Magnesium sulfate .MgSO4 30mg/kg diluted in 30ml normal saline which is instilled through the port by the surgeon after the resection of gall bladder and patient kept trendenlenberg position of about 10 degree after the drug administration and observed for 24 hours post operative period for duration of analgesia and analgesic requirements . |