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CTRI Number  CTRI/2022/09/045555 [Registered on: 15/09/2022] Trial Registered Prospectively
Last Modified On: 03/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Comparison between two drugs,intravenous lignocaine and intravenous magnesium sulphate for decreasing fluctuations of blood pressure, pulse rate during initiation of surgery in patients going for abdominal surgeries. 
Scientific Title of Study   A comparative study between intravenous lignocaine versus intravenous magnesium sulphate for attenuation of haemodynamic stress response during laryngoscopy and tracheal intubation in abdominal surgeries. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepshikha Chakraborty 
Designation  DNB Post graduate trainee 
Affiliation  Ramakrishna Mission Seva Pratisthan And Vivekananda Institute Of Medical Sciences,Kolkata 
Address  Room No 2 DG 5 RKMSP & VIMS Ladies hostel 99, Sarat Bose Road Kolkata 700026
Room No 2 DG 5 RKMSP & VIMS Ladies hostel 99, Sarat Bose Road Kolkata 700026
Kolkata
WEST BENGAL
700026
India 
Phone  8340792031  
Fax    
Email  dips.mishtu17@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  INDRANI CHAKRABORTY MITRA 
Designation  Senior Consultant 
Affiliation  Ramakrishna Mission Seva Pratisthan Vivekananda Institute Of Medical Sciences,Kolkata 
Address  RAMAKRISHNA MISSIN SEVA PRATISHTHAN,V.I.M.S,3RD FLOOR OT COMPLEX,KOLKATA,PIN-700026
RAMAKRISHNA MISSION SEVA PRATISHTHAN,V.I.M.S,3RD FLOOR OT COMPLEX,KOLKATA,PIN-700026
Kolkata
WEST BENGAL
700091
India 
Phone  9830662797  
Fax    
Email  indranimitra7@gmail.com  
 
Details of Contact Person
Public Query
 
Name  INDRANI CHAKRABORTY MITRA 
Designation  Senior Consultant 
Affiliation  Ramakrishna Mission Seva Pratisthan Vivekananda Institute Of Medical illness,Kolkata 
Address  BL55 SECTOR 2 Saltlake City Bidhannagar Kolkata
99, Sarat Bose Road Kolkata 700026
Kolkata
WEST BENGAL
700091
India 
Phone  9830662797  
Fax    
Email  indranimitra7@gmail.com  
 
Source of Monetary or Material Support  
Ramakrishna Mission Seva Pratisthan 
 
Primary Sponsor  
Name  RAMAKRISHNA MISSION SEVA PRATISHTHAN 
Address  99 SARAT BOSE RAMAKRISHNA MISSION SEVA PRATISHTHAN VIMS KOLKATA 700026 
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 
Deepshikha Chakraborty  Ramakrishna Mission Seva Pratisthan Vivekananda Institute Of Medical sciences,Kolkata  4 th floor OT Complex, OT -6 99, Sarat Bose Road Kolkata 700026
Kolkata
WEST BENGAL 
8340792031

dips.mishtu17@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee RKMSP & VIMS  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  A total 120 patients will be enrolled for the study after obtaining a written consent from these patients. These patients will be randomly allocated by rapid sampling into 2 groups of 60 patients each by using computer generated random number table. Two types of coloured balls Red and Yellow would be given to each patient when allocated initially for the study. The patient can pick up any ball at their own discretion. ï‚· Group B –Yellow ball – Allocated for iv Magnesium sulphate ï‚· Group A will receive 2%Lignocaine(without preservative) 1.5 mg/kg IV bolus given over 1 min before induction. Group B will receive 50% Magnesium sulphate 30 mg/kg diluted and made upto 20 ml IV bolus with normal saline, IV bolus over 3 minutes before induction of anaesthesia. 
Comparator Agent  Intravenous Lignocaine  A total 120 patients will be enrolled for the study after obtaining a written consent from these patients. These patients will be randomly allocated by rapid sampling into 2 groups of 60 patients each by using computer generated random number table. Two types of coloured balls Red and Yellow would be given to each patient when allocated initially for the study. The patient can pick up any ball at their own discretion. ï‚· Group A –Red ball – Allocated for iv Lignocaine  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  a Patients posted for surgeries under general anaesthesia
b Patients with ASA Class I and II 
 
ExclusionCriteria 
Details  a Known allergy to anaesthetic agents
b History of a major psychiatric disorder
c History of substance abuse and current opioid use
d Anticipated difficult intubation
e Patients on beta blockers
f Baseline systolic blood pressure (SBP) less than 100 mm Hg
g Compensatory Tachycardia
h Pregnancy
i Diabetic Patients
j Hypertensive patients on medication 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of attenuation of haemodynamic response during induction of general anesthesia between intravenous magnesium sulphate and lignocaine to compare:
HR
SBP
DBP
Any adverse drug reaction  
will be recorded at intubation and 1, 2, 4,6,8, 10 minutes after intubation. 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of attenuation of haemodynamic response including,MAP & RPP during induction of general anesthesia between intravenous magnesium sulphate and lignocaine  Hemodynamic parameters including MAP & RPP and any adverse effect
will be recorded at intubation and 1, 2, 4,6,8, 10 minutes after intubation. 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   20/09/2022 
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="5"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE YET 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
A total 120 patients will be enrolled for the study after obtaining a written consent
from these patients. These patients will be randomly allocated by rapid sampling into
2 groups of 60 patients each by using computer generated random number table. Two
types of coloured balls Red and Yellow would be given to each patient when allocated
initially for the study. The patient can pick up any ball at their own discretion.
 Group A –Red ball – Allocated for iv Lignocaine
Group B –Yellow ball – Allocated for iv Magnesium sulphate
ï‚· Group A will receive 2%Lignocaine(without preservative) 1.5 mg/kg IV bolus given over
1 min before induction. Group B will receive 50% Magnesium sulphate 30 mg/kg
diluted and made upto 20 ml IV bolus with normal saline, IV bolus over 3 minutes
before induction of anaesthesia.
ï‚· Pre-anesthetic evaluation will be done day before OT. All patients will be on NPO for
solid food for 8 hours, for light meal up to 6 hours, for non clear fluid up to 4 hours
and for clear fluids up to 2 hours before the anaesthesia.
 In the operation theater, the patient’s body weight, fasting status, consent, and preanaesthetic
check up will be checked, i.v cannula will be established. Standard
monitors like ECG, Pulse oximeter, NIBP will be connected to the patients and baseline
heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean
arterial blood pressure (MAP), Rate Pressure Product (RPP) will be noted.
ï‚· Rate pressure product will be calculated from recordings of SBP and HR (formula: SBP
x HR), which will be recorded at various time intervals. The RPP is an index of
myocardial oxygen demand.
ï‚· All patients will be premedicated by midazolam 0.2 mg/kg IV and patients according
to their respective group will receive (without preservative) Lignocaine or Magnesium
sulphate and hemodynamic parameters will be recorded after 10 minutes from the
time of administration of the Lignocaine or Magnesium sulphate. Then after 10
minutes of initiation of infusion of (without preservative) Lignocaine or Magnesium
sulphate, general anaesthesia will be induced by IV Fentanyl 1-1.5 μg/kg, Propofol 1-
2 mg/kg. After achieving proper mask ventilation Atracurium 0.5 mg/kg will be given
16
to facilitate tracheal intubation. Then the patient will be mask ventilated for 3 minutes
followed by laryngoscopy and endotracheal intubation; then Atracurium 0.1 mg/kg
will be given as maintenance at regular intervals.
ï‚· According to patient haemodynamics, anaesthesia will be maintained with Nitrous
oxide 60%, Isoflurane 0.6-1.0% in 40% oxygen. The lungs will be mechanically
ventilated and the end-tidal carbon dioxide concentration will be maintained at 30-40
mm Hg. No surgical or any other stimulus will be applied during 10 minutes of study
period.
ï‚· Hemodynamic parameters including HR, SBP, DBP, MAP, RPP and any adverse effect
will be recorded at intubation and 1, 2, 4,6,8, 10 minutes after intubation.
At the end of the surgery, neuromuscular block will be reversed with Neostigmine at
a dosage 0.05 mg/kg iv and Glycopyrrolate at a dose of 0.004 mg/kg/iv dose.
ï‚· Premedication with iv Lignocaine or iv Magnesium sulphate before induction of
general anesthesia during Laryngoscopy and Tracheal intubation helps in attenuation
of haemodynamic stress response and have no as such side effects per say, both these
drugs can be used interchangeably without affecting the safety of the patients.
ï‚· 
 
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