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CTRI Number  CTRI/2025/08/092739 [Registered on: 11/08/2025] Trial Registered Prospectively
Last Modified On: 09/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare blood pressure response to tracheal intubation in patients undergoing surgery under general anaesthesia 
Scientific Title of Study   EVALUATION OF TWO DIFFERENT DOSES OF NEBULISED DEXMEDETOMIDINE ON ATTENUATING HEMODYNAMIC STRESS RESPONSE TO LARYNGOSCOPY AND INTUBATION IN PATIENTS UNDERGOING SURGERY UNDER GENERAL ANAESTHESIA:A DOUBLE BLINDED RANDOMISED CONTROLLED STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anilkumar Ganeshnavar 
Designation  Professor  
Affiliation  S Nijalingappa Medical College 
Address  Department of Anaesthesiology SNMC and HSK Hospital,Navanagar, Bagalkot-587102

Bagalkot
KARNATAKA
587102
India 
Phone  9964526598  
Fax    
Email  anilganesh22@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anilkumar Ganeshnavar 
Designation  Professor  
Affiliation  S Nijalingappa Medical College 
Address  Department of Anaesthesiology SNMC and HSK Hospital,Navanagar, Bagalkot-587102

Bagalkot
KARNATAKA
587102
India 
Phone  9964526598  
Fax    
Email  anilganesh22@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Soundarya G R 
Designation  Junior Resident 
Affiliation  S Nijalingappa Medical College 
Address  Department of Anaesthesiology SNMC and HSK Hospital,Navanagar, Bagalkot-587102

Bagalkot
KARNATAKA
587102
India 
Phone  6363295470  
Fax    
Email  soundaryagr22497@gmail.com  
 
Source of Monetary or Material Support  
Patients coming to S N Medical college and HSK hospital posted for elective surgery under GA who wish to participate in trial voluntarily 
 
Primary Sponsor  
Name  S Nijalingappa medical college 
Address  Department of Anesthesiology, SNMC and HSK Hospital,navanagar Bagalkot-587102 Karnataka 
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 Anil kumar Ganeshnavar  S Nijalingappa Medical College and hsk hospital   Major OT complex 1st floor IPD Block
Bagalkot
KARNATAKA 
9964526598

anilganesh22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
S NIJALINGAPPA MEDICAL COLLEGE AND HANAGAL SHRI KUMARESHWAR HOSPITAL AND RESEARCH CENTRE BAGALKOT  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H661||Chronic tubotympanic suppurative otitis media,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nebulisation  The procedure will be performed 15 minutes before the anticipated intubation Group A 1mcg/kg nebulized dexmedetomidine with 5ml normal saline Group B 2mcg/kg nebulized dexmedetomidine with 5ml normal saline  
Comparator Agent  To compare haemodynamic stress response between two doses  1. To estimate and compare the hemodynamic parameters HR SBP MAP in between two doses of dexmedetomidine at various time interval T1 after nebulization T2 before tracheal intubation T3 after tracheal intubation T4 5minutes after tracheal intubation T5 at the closure of the skin incision T6 immediately after tracheal extubation T7 5 minutes after tracheal extubation 2. To assess and compare the cough response at extubation and the incidence rate of postoperative sore throat between group A and group B. at 0 2nd 4th and 6th hour after extubation  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adult patients of ages 20 to 60 years
American Society of Anaesthesiologists grade I or II of both gender
Patients undergoing elective surgery requiring GA
 
 
ExclusionCriteria 
Details  Patient with a history of sore throat or upper respiratory tract infection
Hemodynamically unstable patients
Emergency patients
Patents with a history of allergy to dexmedetomidine
5. Patients with a history of cardiac, liver, or renal disorders.
6. Patient with a difficult airway where the anticipated
duration of laryngoscopy exceeded 15 seconds

 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To estimate and compare two different doses Group-A (1mcg/kg) and Group-B (2mcg/kg) of nebulized dexmedetomidine to attenuate haemodynamic stress response to laryngoscopy and intubation at different time interval during intubation  THE PRIMARY OBJECTIVE PARAMETERS WILL BE MEASURED AT VARIOUS TIME POINT ARE
T0 baseline before the procedure of nebulization
T1 after nebulization
T2 before tracheal intubation
T3 after tracheal intubation
T4 5 minutes after tracheal intubation
T5 at the closure of skin incision
T6 immediately after tracheal extubation
T7 5 minutes after tracheal extubation
 
 
Secondary Outcome  
Outcome  TimePoints 
1. To estimate and compare the hemodynamic parameters in group A and group B at extubation.
2. To assess and compare the cough response at extubation and the incidence rate of postoperative sore throat between group A and group B.
 
6hours 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   25/08/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   The larynx is a richly innervated structure with abundant neurovascular supply. Laryngoscopy and tracheal intubation are generally associated with pressure on the larynx, which results in the activation of somatovisceral reflexes. Sympathoadrenal activation leads to the release of catecholamines, which results in a rise in hemodynamics. The duration of the intubation and the force exerted during the procedure directly affect the catecholamine response.It starts within 5–10 seconds, peaking at 1–2 minutes, and finally returning to its baseline readings in the next 5 minutes. Although this is a transient response with an average rise in systolic blood pressure (SBP) of 25–30 mmHg, and most healthy patients tolerate it without any untoward effect, it may prove to be extremely deleterious in patients with cerebrovascular or cardiovascular diseases.
It has been associated with the precipitation of cardiac ischemia, cerebral stroke ,pulmonary edema. various preemptive measures are used to attenuate this response ,mainly addressed by intravenous or local agents. Most commonly employed alfa -2 agonist agonist ,opioids, beta blockers and local anesthetics .All of them are associated with various systemic side effects such as opioids with reduced respiratory drive, sedation, and postoperative nausea and vomiting and selective alfa 2 agonists such as dexmedetomidine with hypotension and bradycardia. Most of these are used preemptively but very few are administered through the nebulisation route. Direct instillation through nebulisation is new area with lesser systemic effects, which needs to be explored.
Dexmedetomidine, an alpha 2 agonist, had been widely studied through the intravenous route where it has repeatedly proven itself to suppress the hemodynamic stress response, but systemic side effects such as hypotension and bradycardia are commonly associated, which may be troublesome. However, the recent literature has stated that the nebulization route has better bioavailability: nasal mucosa—65% and buccal mucosa—82%.
Nebulised dexmeditomidine has been reported with a very short distribution half life (6minutes) and elimination half-life(2hours) withoit being associated with systemic side effects.It has reported in literature that dexmedetomidine when administered through the nebulisation route had reduced stress response to laryngoscopy and intubation also reported that nebulised dexmeditomidine can attenuate the postoperative sore throat in patients.
 
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