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CTRI Number  CTRI/2022/12/048494 [Registered on: 26/12/2022] Trial Registered Prospectively
Last Modified On: 03/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare the Magnesium sulphate nebulization versus intravenous infusion of Magnesium Sulphate in controlling post- intubation hemodynamic and stress response in adult patients undergoing scheduled surgeries. 
Scientific Title of Study   A comparative study of preoperative Magnesium sulphate nebulization versus intravenous infusion of Magnesium sulphate in controlling post- intubation hemodynamic and stress response in adult patients undergoing elective surgeries. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pooja Kumari 
Designation  Post graduate resident 
Affiliation  Vardhman Mahavir medical college and Safdarjung hospital 
Address  Department of Anaesthesia and Intensive care, Vardhman Mahavir medical college and Safdarjung hospital,Ansari Nagar,New Delhi South Delhi

South
DELHI
110029
India 
Phone  9319304774  
Fax    
Email  kpooja004004@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Amita Gupta 
Designation  Professor and consultant 
Affiliation  Vardhman Mahavir Medical College and Safdarjung hospital 
Address  Department of Anaesthesia and Intensive care Vardhman Mahavir Medical College and Safdarjung hospital, Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  9910382190  
Fax    
Email  amitaguptadr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Amita Gupta 
Designation  Professor and consultant 
Affiliation  Vardhman Mahavir Medical College and Safdarjung hospital 
Address  Department of Anaesthesia and Intensive care Vardhman Mahavir Medical College and Safdarjung hospital, Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  9910382190  
Fax    
Email  amitaguptadr@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesia VMMC and Safdarjung hospital Delhi 
 
Primary Sponsor  
Name  Department of anaesthesia and critical care 
Address  Department of anaesthesia VMMC and Safdarjung hospital South Delhi  
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 
DR POOJA KUMARI  Vardhman Mahavir Medical College and Safdarjung hospital  Department of Anaesthesia and Intensive care Ansari Nagar, New Delhi
South
DELHI 		 9319304774

kpooja004004@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
VMMC and Safdarjung Hospital Institutional Protocol Review Committee  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 
Intervention  Magnesium sulphate  Intravenous infusion of magnesium sulphate at a dose of 30mg/kg in 100 ml solution over 20 minutes before intubation. 
Intervention  Magnesium sulphate  Nebulization with 300mg magnesium sulphate in diluted soltution of 5ml over 10 minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Both male and female between the age of 18 to 65 will be included. 
 
ExclusionCriteria 
Details  History of hypersensitivity to magnesium sulphate.
Anticipated difficult airway.
Patients on steroid therapy.
Patients on psychiatric medication.
Pregnancy
Anticipated major fluid shift surgeries. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Changes in Hemodynamic parameters following laryngoscopy and intubation in terms of:
1)Heart rate
2) Systolic blood pressure
3)Diastolic blood pressure
4)Mean arterial pressure 		 At different time intervals:
Baseline (T0)
Post intervention/pre-induction(T1)
Just before laryngoscopy(T2)
1 min.post-intubation(T3)
3 min.post-intubation(T4)
5 min.post-intubation(T5)
10 min.post-intubation(T6) 
 
Secondary Outcome  
Outcome  TimePoints 
1)Serum Cortisol level
2)Serum magnesium level 		 1)Serum Cortisol level:
Baseline
Post intubation (15 min)
2)Serum magnesium level:
Baseline
Post intubation (15 min)
 
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2023 
Date of Study Completion (India) 03/02/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
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
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kpooja004004@gmail.com].

  6. For how long will this data be available start date provided 10-06-2024 and end date provided 01-01-2080?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 It is a comparative study of preoperative magnesium sulphate nebulization versus intravenous infusion of magnesium sulphate in controlling post- intubation hemodynamic and stress response in adult patients undergoing elective surgeries.
A total number of 130 patients between the age 18 to 65, undergoing elective surgeries will be assigned into 2 groups, group I and group N by Block randomization with sealed envelope  system. There will be 65 patients in each group.
Group I will receive intravenous magnesium sulphate and group N will receive magnesium sulphate nebulization.
Primary objective will be to compare the changes in hemodynamic parameters between both groups in terms of Heart rate, Systolic blood pressure, Diastolic blood pressure, Mean arterial pressure, at different time intervals  following laryngoscopy and intubation: Baseline (T0), Post intervention/pre-induction(T1), Just before laryngoscopy(T2), 1 min.post-intubation(T3), 3 min.post-intubation(T4), 5 min.post-intubation(T5), 10 min.post-intubation(T6) 
Secondary objectives will be to compare : 1)Serum Cortisol level: Baseline and Post intubation (15 min) 2)Serum magnesium level:Baseline and Post intubation (15 min), between both groups.

 
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