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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 . 
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