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CTRI Number  CTRI/2024/03/064545 [Registered on: 20/03/2024] Trial Registered Prospectively
Last Modified On: 19/03/2024
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   Effectiveness of Magnesium and Lignocaine in Reducing Stress During Airway Procedures: A Clinical Trial 
Scientific Title of Study   TO STUDY THE EFFICACY OF INTRAVENOUS MAGNESIUM SULPHATE WITH AND WITHOUT LIGNOCAINE SPRAY IN ATTENTUATING THE PRESSOR RESPONSE TO LARYNGOSCOPY AND INTUBATION 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Harini P 
Designation  Post graduate 
Affiliation  Mahatma Gandhi medical college, Pondicherry 
Address  Department of Anaesthesiology, 2nd floor, Mahatma Gandhi medical college and research institute, Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  7358595571  
Fax    
Email  hariniparani98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Hemanth Kumar V R 
Designation  Professor, Head of department 
Affiliation  Mahatma Gandhi medical college, Pondicherry 
Address  Department of Anaesthesiology, 2nd floor, Mahatma Gandhi medical college and research institute, Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9003550553  
Fax    
Email  drvrhk@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Hemanth Kumar V R 
Designation  Professor, Head of department 
Affiliation  Mahatma Gandhi medical college, Pondicherry 
Address  Department of Anaesthesiology, 2nd floor, Mahatma Gandhi medical college and research institute, Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9003550553  
Fax    
Email  drvrhk@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Mahatma Gandhi medical college 
Address  Mahatma Gandhi medical college and research institute, Pondicherry - 607402 
Type of Sponsor  Private 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 Harini P  Mahatma gandhi medical college and research institute  room number- 201, Department of anaesthesiology, 2nd floor, Mahatma Gandhi medical college and research institute, pondicherry
Pondicherry
PONDICHERRY 
7358595571

hariniparani98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional human ethics committee, MGMCRI, Puducherry  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 magnesium sulphate (30mg/kg) with 10% lignocaine spray on the vocal cords  to assess the pressor response attenuation during intubation with intravenous magnesium sulphate (30mg/kg) before induction of general anaesthesia and 10% lignocaine spray (4 puffs) on the vocal cords before intubation.  
Intervention  with intravenous magnesium sulphate (30mg/kg)  to assess the pressor response attenuation during intubation with intravenous magnesium sulphate (30mg/kg) given before induction of general anaesthesia in ASA 1 and 2 patients. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. patients belonging to ASA grade I, II.
2. Patients posted for surgery under general anaesthesia
3. AGE - 18-60 years of age
4. SEX - Male and Female
 
 
ExclusionCriteria 
Details  history of allergic to local anaesthetic agents
Patients with coronary artery disease
Difficult airway
hypertensive patients on two or more medications
BMI greater than 30 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess and compare the Heart rate and blood pressure variation due to pressor response between the two study groups.
 
To assess baseline heart rate and blood pressure and the variations after the administration of the test drug, during intubation, 2 minutes, 4 minutes, 6 minutes, 8 minutes and at 10 minutes after intubation. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess sedation score post extubation using Ramsay sedation scale between the two groups.   to be assessed before shifting the patient to recovery room. 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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)   31/03/2024 
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="0"
Months="8"
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  

Depending on the study drug to be administered, the chosen patients will be randomized into 2 Groups, ML and M by computer generated randomization using sealedenvelope.com. Concealment will be done using sealed envelope technique. Group ML will receive intravenous MgSO4 (30 mg/kg) and 10% lignocaine spray; Group M will get intravenous MgSO4 (30 mg/kg).

All patients will be pre-medicated with tab. Alprazolam 0.5 mg oral, the night before surgery and a minimum fasting state of six hours before anaesthesia will be ensured in all patients. On arrival in the operating room, standard monitoring such as electrocardiography, pulse oximetry (SpO2), non-invasive blood pressure monitoring will be connected to the patient and the baseline heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) were recorded.

Prior to induction, pre-medications such as inj. Midazolam 0.05 mg/kg IV and inj. Morphine 0.1 mg/kg IV will be given, and all patients will be preoxygenated with 100% oxygen for three minutes. Prior to induction, both the groups will receive intravenous magnesium sulphate 30mg/kg as slow iv over two minutes. Induction will be carried out with injection propofol till the loss of verbal response. Muscle relaxation will be achieved with inj. vecuronium 0.1mg/kg after assessing adequacy of mask ventilation.  Positive pressure mask ventilation will be provided to ensure adequate oxygenation and ventilation. Three minutes after giving vecuronium, laryngoscopy will be done, following which group ML patients will receive 10% Lignocaine spray. Positive pressure mask ventilation will be provided for two minutes after which laryngoscopy and tracheal intubation will be done. In group M, after administration of vecuronium, positive pressure mask ventilation will be done for three minutes. Then, laryngoscopy will be done followed by endotracheal intubation. An experienced anaesthesiologist will perform the laryngoscopy, and a suitable-sized cuffed endotracheal tube will be used for orotracheal intubation. Only patients whose intubation will be performed in a single try within 20 seconds and using a standard McIntosh curved blade laryngoscope will be included in the study. After intubation, surgical stimulation will not be allowed for 10 minutes. Maintenance of general anaesthesia, intraoperative monitoring and reversal of neuro-muscular blockade and extubation following the standard practice.

Parameters like Heart Rate (HR); systolic blood pressure (SBP); diastolic blood pressure (DBP); mean arterial pressure (MAP) will be recorded at Baseline; after administration of the study drug; after administration of propofol; at laryngoscopy with spraying, immediately after intubation; at two, four, six, eight and at 10 minutes after induction. Patients will be carefully monitored for any complications including hypotension and bradycardia which will be managed by Inj. Mephentermine and Inj. Atropine accordingly.

 
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