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CTRI Number  CTRI/2025/04/085989 [Registered on: 30/04/2025] Trial Registered Prospectively
Last Modified On: 29/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison between Nitroglycerine and Lignocaine spray for reducing blood pressure and heart rate response during laryngoscopy and intubation in patients undergoing elective surgeries 
Scientific Title of Study   Comparison between Nitroglycerine and Lignocaine spray for attenuation of pressor response during laryngoscopy and endotracheal intubation in patients undergoing elective surgery under general anaesthesia  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kavin Prasad M 
Designation  DNB resident  
Affiliation  Narayana Hrudayalaya ,Narayana Health City  
Address  Department of anesthesiology,4th floor anesthesia office B block OT and SICU complex,Mazumdar Shaw Medical Center,Narayana Hrudalaya,Narayana Health City,Bommasandra,Bangalore

Bangalore
KARNATAKA
560099
India 
Phone  9659159266  
Fax    
Email  504116@narayanahealth.org  
 
Details of Contact Person
Scientific Query  
Name  Dr.Indumathi T 
Designation  Consultant  
Affiliation  Narayana Hrudayalaya ,Narayana Health City  
Address  Department of anesthesiology,4th floor anesthesia office B block OT and SICU complex,Mazumdar Shaw Medical Center,Narayana Hrudalaya,Narayana Health City,Bommasandra,Bangalore

Bangalore
KARNATAKA
560099
India 
Phone  9538533850  
Fax    
Email  indumathi.t.dr01@narayanahealth.org  
 
Details of Contact Person
Public Query  
Name  Dr Kavin Prasad M 
Designation  DNB resident  
Affiliation  Narayana Hrudayalaya ,Narayana Health City  
Address  Department of anesthesiology,4th floor anesthesia office B block OT and SICU complex,Mazumdar Shaw Medical Center,Narayana Hrudalaya,Narayana Health City,Bommasandra,Bangalore

Bangalore
KARNATAKA
560099
India 
Phone  9659159266  
Fax    
Email  504116@narayanahealth.org  
 
Source of Monetary or Material Support  
Narayana Hrudayalaya hospital, Bommasandra, Bangalore, Karnataka, India PIN-560099 
 
Primary Sponsor  
Name  Narayana Hrudayalaya hospital  
Address  Narayana Hrudayalaya hospital, Bommasandra,Bangalore,Karnataka,India 560099 
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 Kavin Prasad M  Narayana Health City   Department of anesthesiology,4th floor anesthesia office B block OT and SICU complex,Mazumdar Shaw Medical Center, Bommasandra
Bangalore
KARNATAKA 		 9659159266

504116@narayanahealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NARAYANA HEALTH ACADEMIC ETHICS 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  Attenuation of pressor response to endotracheal intubation   Patients posted for elective surgery under general anaesthesia will be considered for the study. The patients will be randomly divided and group N will be given Nitroglycerine spray 800 mcg and group L will be given 20mg oropharyngeal and 20 mg Vocal cord Lignocaine spray 60s prior to laryngoscopy and intubation and heart rate , systolic and diastolic blood pressure will be recorded at baseline , at the time of intubation and till 15 mins after intubation. 
Comparator Agent  Lignocaine spray  Giving lignocaine spray 20mg oropharyngeal and 20 mg Vocal cord spray 60s prior to laryngoscopy and intubation and comparing its efficacy with sublingual Nitroglycerine spray 800mcg given 60s prior to intubation in reducing the pressor response to intubation and monitoring the blood pressure , heart rate and saturation before , during and till 15 minutes after intubation 
Comparator Agent  Nitroglycerine spray  Giving nitroglycerine spray 800mcg 60s prior to laryngoscopy and intubation and comparing its efficacy in reducing pressor response to intubation with lignocaine spray 20mg oropharyngeal and 20 mg Vocal cord spray 60s prior to intubation and monitoring the blood pressure , heart rate and saturation before , during and till 15 minutes after intubation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients of American Society of Anesthesiologists (ASA) physical status grade I and II undergoing elective surgery under general anesthesia. 
 
ExclusionCriteria 
Details  Patient refusal ,patients with ischemic /Valvular heart disease , Renal and liver dysfunction and patients with known hypersensitivity to Lignocaine and Nitroglycerine are excluded. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the systolic blood pressure variation between the two groups at baseline , at the time of intubation and till 15 mins post intubation.  To compare the systolic blood pressure variation between the two groups at baseline , at the time of intubation and till 15 mins post intubation. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the heart rate , diastolic blood pressure & mean arterial pressure between the two groups at baseline , at the time of intubation andtill 15 mins post intubation.  To compare the heart rate , diastolic blood pressure & mean arterial pressure between the two groups at baseline , at the time of intubation & till 15 mins post intubation. 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
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 4 
Date of First Enrollment (India)   10/05/2025 
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="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 - NO
Brief Summary   Laryngoscopy and intubation are painful stimuli which leads to tachycardia , hypertension and arrhythmias. This hemodynamic stress response to airway instrumentation is due to the activation of sympatho-adrenergic response causing increase in the circulating catecholamines causing increase in heart rate and blood pressure .

While these changes are tolerated by a normal healthy patient ,these may be fatal in patients with coronary artery disease , Hypertension,  intracranial aneurysm , cerebrovascular disease and may cause MI , arrhythmias , left ventricular failure and rupture of aneurysm.

NITROGLYCERINE causes vascular smooth muscle dilatation through cGMP activated pathways leading to the desired vasodilatory effect. 

LIGNOCAINE causes hypotension through two mechanisms- the first is the dose dependant negative inotropic action by blocking calcium influx in the heart. Second by blurting the airway reflexes. 
 
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