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CTRI Number  CTRI/2023/08/055967 [Registered on: 01/08/2023] Trial Registered Prospectively
Last Modified On: 23/07/2023
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   To study the effect of injection magnesium sulphate on responses to heart rate and blood pressure during intubation in surgeries of ear, nose and throat 
Scientific Title of Study   Evaluation of intravenous magnesium sulphate on haemodynamic responses to laryngoscopy and tracheal intubation in surgeries of ear, nose and throat 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Urvi Arun Sawant 
Designation  Junior Resident 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Anaesthesia, Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe) , Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9920392939  
Fax    
Email  urvisawant1129@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jayashree Sen  
Designation  Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Anaesthesia, Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe) , Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9813061192  
Fax    
Email  jayashree_sen@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Urvi Arun Sawant 
Designation  Junior Resident 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Anaesthesia, Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe) , Wardha

Wardha
MAHARASHTRA
442001
India 
Phone  9920392939  
Fax    
Email  urvisawant1129@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Medical College,Sawangi , Meghe  
 
Primary Sponsor  
Name  Jawaharlal Nehru Medical College 
Address  Department of Anaesthesia, Datta Meghe Institute of Higher Education and Research 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Jawaharlal Nehru Medical College  Department of Anaesthesia, Datta Meghe Institute of Higher Education and Research 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Urvi Arun Sawant  Acharya Vinoba Bhave Rural Hospital  Department of Anesthesiology, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe)
Wardha
MAHARASHTRA 		 9920392939

urvisawant1129@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H758||Other specified disorders of middle ear and mastoid in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intravenous magnesium sulphate  Magnesium sulphate (MgSO4) inhibits catecholamine release from adrenal glands, thus reducing the levels of serum epinephrine, causes a decrease in the atrial contraction, bradycardia, and vasodilatation. Hence the study would evaluate the efficacy of intravenous magnesium sulphate on haemodynamic responses during laryngoscopy and tracheal intubation and the hemodynamic responses in form of heart rate , blood pressure and mean arterial pressure will be monitored at 1 , 3 and 5 minutes of administration of the drug. 
Comparator Agent  Normal saline  During intubation normal saline will be administered intravenously and the hemodynamic response in form of heart rate , blood pressure and mean arterial pressure will be monitored at 1 , 3 and 5 minutes of the procedure. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Weight between 40-65 kg, either gender , ASA physical status I and II, patients undergoing elective ENT surgery. 
 
ExclusionCriteria 
Details  Patient refusal , emergency surgery. History of cardiovascular , pulmonary, renal , hepatic , endocrinal or neurological disease. Preoperative hypotension , patients on antipsychotics. Patient on digitalis , calcium channel blockers and alpha & beta agonist or antagonist . Sinus bradycardia, heart blocks, conduction defects. Obesity, pregnancy , lactation, anticipated difficult airway, allergy to study drugs. Any change needed in the technique of anesthesia or duration of laryngoscopy for >30 seconds. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Magnesium sulphate is effective in suppressing the haemodynamic responses to laryngoscopy & tracheal intubation in surgeries of ear, nose & throat.  Until 5 minutes after laryngoscopy 
 
Secondary Outcome  
Outcome  TimePoints 
To observe the incidence & severity of adverse effects of intravenous magnesium sulphate, if any.  Until 5 minutes after laryngoscopy 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 
Date of First Enrollment (India)   01/08/2023 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 (Others) -  will be decided later

  6. For how long will this data be available start date provided 31-12-2024 and end date provided 31-12-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   The aim of the study is to evaluate the efficacy of intravenous magnesium sulphate on haemodynamic responses during laryngoscopy and tracheal intubation. The objective is to also observe the incidence and severity of adverse effects of intravenous magnesium sulphate. Magnesium sulphate will be administered over a period of 1 minute prior to induction along with general anaesthesia. During laryngoscopy , patient’s haemodynamic parameters will be recorded non invasively at prescribed time intervals. 
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