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CTRI Number  CTRI/2024/03/063795 [Registered on: 07/03/2024] Trial Registered Prospectively
Last Modified On: 03/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to compare the effectiveness of magnesium sulfate over 0.9% saline in preventing haemodynamic response associated with inflation of abdomen with carbon dioxide during laparoscopic surgeries. 
Scientific Title of Study   Evaluate the safety and efficacy of magnesium sulfate on hemodynamic respose to pneumoperitonium in patients undergoing laparoscopic surgeries.A placebo controlled single blind randomized 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  BINDIYA GAUTAM 
Designation  post graduate resident 
Affiliation  DY PATIL UNIVERSITY SCHOOL OF MEDICINE NAVI MUMBAI 
Address  A Wing Department of Anaesthesia D Y Patil university school of medicine Ayyappa temple road Sector 7 Nerul Navi Mumbai

Mumbai
MAHARASHTRA
400706
India 
Phone  8970050435  
Fax    
Email  bindigautam999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. R P Gehdoo 
Designation  Professor 
Affiliation  DY PATIL UNIVERSITY SCHOOL OF MEDICINE NAVI MUMBAI 
Address  A Wing Department of Anaesthesia D Y Patil university school of medicine Ayyappa temple road Sector 7 Nerul Navi Mumbai

Mumbai
MAHARASHTRA
400706
India 
Phone  9820517674  
Fax    
Email  rpgehdoo123@gmail.com  
 
Details of Contact Person
Public Query  
Name  BINDIYA GAUTAM 
Designation  Post graduate resident 
Affiliation  DY PATIL UNIVERSITY SCHOOL OF MEDICINE NAVI MUMBAI 
Address  A Wing Department of Anaesthesia D Y Patil university school of medicine Ayyappa temple road Sector 7 Nerul Navi Mumbai


MAHARASHTRA
400706
India 
Phone  8970050435  
Fax    
Email  bindigautam999@gmail.com  
 
Source of Monetary or Material Support  
D Y Patil University School Of Medicine, Nerul Navi Mumbai Maharashtra 400706 
 
Primary Sponsor  
Name  D Y Patil University School Of Medicine 
Address  Ayyappa Temple Road sector 5 Vidya Nagar Nerul Navi Mumbai Maharashtra 400706 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Bindiya Gautam  D Y Patil University School Of Medicine  A Wing Department of Anaesthesia D Y Patil university school of medicine Ayyappa temple road Sector 7 Nerul Navi Mumbai
Mumbai
MAHARASHTRA 		 8970050435

bindigautam999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IECBH of Dr. DY Patil Medical College and Hospital, Navi Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intravenous 0.9% normal saline  Frequency - Single Dose Route of Administration - Intravenous Duration of Intervention - 10 minutes  
Intervention  Intravenous Magnesium sulfate  Frequency - Single Dose Route of Administration - Intravenous Duration of Intervention - 10 minutes before pneumoperitoneum 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Eletive laparoscopic surgeries done under general anesthesia.
Patients between 18 to 60 years.
ASA grade I and II.
Patients giving consent for study. 
 
ExclusionCriteria 
Details  Patients not willing to participate in study
Patients with hypermagnesemia.
Patients with morbid obesity, severe hepatic, renal, endocrine and cardiac dysfunction.
Pregnant and lactating patients. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Study the effect of magnesium sulfate on haemodynamic changes heart rate, systolic BP, diastolic BP, mean arterial pressure during laparoscopic surgeries.  Study the effect of magnesium sulfate on haemodynamic changes heart rate, systolic BP, diastolic BP, mean arterial pressure in laparoscopic surgeries before pneumoperitoneum and every 15 minutes from pneumoperitoneum. 
 
Secondary Outcome  
Outcome  TimePoints 
to assess the need for rescue drug  during surgery 
 
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 4 
Date of First Enrollment (India)   15/03/2024 
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="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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [bindigautam999@gmail.com].

  6. For how long will this data be available start date provided 20-02-2025 and end date provided 20-02-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Randomized prospective controlled comparative study to investigate the efficacy of magnesium sulfate Vs 0.9% saline in preventing adverse hemodynamic response associated with pneumoperitoeium in patients undergoing laparoscopic surgeries .
patients will be randomly allocated into 2 groups of 30 patients each. One group will receive magnesium sulfate 30mg/kg body weight IV before pneumoperitoneum and the other group will receive same volume of 0.9% saline. Values of heart rate , blood pressure , mean arterial pressure and oxygen saturation will be recorded before and after pneumoperitoneum.
 
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