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CTRI Number  CTRI/2023/10/058354 [Registered on: 05/10/2023] Trial Registered Prospectively
Last Modified On: 29/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison between magnesium sulphate and lignocaine for preventing stress on heart during laryngoscopy and endotracheal intubation in patients undergoing surgeries under general anesthesia 
Scientific Title of Study   Comparison of intravenous magnesium sulphate and intravenous lignocaine for attenuation of cardiovascular response to laryngoscopy and endotracheal intubation in patients undergoing elective surgeries under general anaesthesia - A one year hospital based double blinded Randomised Clinical Trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kishore B J 
Designation  Junior resident  
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Anesthesiology, Dr Prabhakar Kore Hospital, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9972431072  
Fax    
Email  kishore.jayaprakash@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kedareshvara KS 
Designation  Professor 
Affiliation  Jawaharlal Nehru Medical College  
Address  Department of Anesthesiology, Dr Prabhakar Kore Hospital, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9886375154  
Fax    
Email  kedareshvara@gmail.com  
 
Details of Contact Person
Public Query  
Name  Kishore B J 
Designation  Junior resident 
Affiliation  Jawaharlal Nehru Medical College  
Address  Department of Anesthesiology, Dr Prabhakar Kore Hospital, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9972431072  
Fax    
Email  kishore.jayaprakash@gmail.com  
 
Source of Monetary or Material Support  
Dr Prabhakar Kore Hospital, Nehru Nagar, Belagavi- 590010 
 
Primary Sponsor  
Name  Dr Prabhakar Kore Hospital 
Address  Nehru Nagar, Belagavi- 590010 
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 Kishore B J  Dr Prabhakar Kore Hospital   Department of Anesthesiology, Dr Prabhakar Kore Hospital, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi
Belgaum
KARNATAKA 		 9972431072

kishore.jayaprakash@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Institutional Ethics Committee, Jawaharlal Nehru Medical College   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  Intravenous Magnesium Sulphate   Intravenous Magnesium Sulphate 50%, 30mg/kg slow intravenous stat, 3 min before intubation, vitals from time of intubation upto 10 min 
Comparator Agent  Intravenous preservative free lignocaine   Intravenous preservative free lignocaine, 1.5 mg/JG intravenous stat, 3 min before intubation, vitals from the time of intubation upto 10 min 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. ASA physical status I and II
2. Patients undergoing elective surgeries under general anesthesia
3. Patients providing consent 
 
ExclusionCriteria 
Details  1. Patients allergic to drugs under study
2. Patients with contraindication to general anesthesia
3. Patient refusal or who are unable to give consent
4. Patients undergoing emergency surgeries
5. Patients with significant cardiac and respiratory diseases
6. Patients with difficult airway
7. Pregnancy
8. Patients with oral and nasal pathology 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare intravenous lignocaine with intravenous magnesium sulphate with respect to:
Hemodynamic variables - Mean arterial pressure, Systolic blood pressure, Diastolic blood pressure, Heart rate 		 At baseline (before intubation), and at 1 min, 2 min, 3 min, 4min, 5min, 7 min, 10 min after intubation 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of side effects & complications if any of the study drugs  From the time of administering the drugs till the end of the surgical procedure 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
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 3 
Date of First Enrollment (India)   15/10/2023 
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="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 - NO
Brief Summary          Laryngoscopy and endotracheal intubation are essential components of general anesthesia. 
       But laryngoscopy results in stimulation of larynx, pharynx and trachea, which are extensively innervated by the autonomic nervous system, activation of which leading to various cardiovascular changes, dysrhythmias that may end up in stroke or cardiac arrest due to hemodynamic instability. 
       Therefore, in recent times, it has become important to find an effective means of attenuating of sympathetic response to laryngoscopy and intubation and is one of the most researched topics in the field of anesthesiology.
       Hesitation of using magnesium sulphate by anesthesiologists is seen although its efficacy is internationally proven and thus local data is deficient. 
       Thus, this study was designed to give a holistic view regarding the clinical importance of magnesium sulphate in blunting hemodynamic response to tracheal intubation during elective surgeries. 
       Therefore, aim of this study was to compare the hemodynamic stability during laryngoscopy with magnesium sulphate versus commonly used drug lignocaine in patients undergoing elective surgeries at a tertiary care center.
 
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