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CTRI Number  CTRI/2025/09/094340 [Registered on: 08/09/2025] Trial Registered Prospectively
Last Modified On: 07/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Comparative study between the effects of two doses of nebulized Dexmedetomidine as premedication in attenuating the hemodynamic response to laryngoscopy and endotracheal intubation in a tertiary care hospital 
Scientific Title of Study   A Comparative study between the effects of two doses of nebulized Dexmedetomidine as a premedication in attenuating the hemodynamic response to laryngoscopy and endotracheal 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  Dr. D G Rakshitha  
Designation  2 nd year Post graduate  
Affiliation  Kodagu institute of medical scinces 
Address  Department of Anaesthesia Kodagu institute of medical scinces, near G T Circle

Kodagu
KARNATAKA
571201
India 
Phone  7892746957  
Fax    
Email  raksharh6@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Aiyappa D S 
Designation  Associate Professor  
Affiliation  Kodagu institute of medical scinces 
Address  Department of Anaesthesia Kodagu institute of medical scinces, Near G T circle

Kodagu
KARNATAKA
571201
India 
Phone  9986336771  
Fax    
Email  draiyappads@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Aiyappa D S 
Designation  Associate Professor 
Affiliation  Kodagu institute of medical scinces 
Address  Department of Anaesthesia Kodagu institute of medical scinces, Near G T Circle

Kodagu
KARNATAKA
571201
India 
Phone  9986336771  
Fax    
Email  draiyappads@gmail.com  
 
Source of Monetary or Material Support  
Kodagu institute of medical scinces, near G T Circle madikeri, Karnataka, India Pin code: 571201  
 
Primary Sponsor  
Name  Dr D G Rakshitha  
Address  Kodagu institute of medical scinces, near G T Circle madikeri, Karnataka, India. Pin code: 571201 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 D G Rakshitha  Kodagu institute of medical sciences  Department of Anaesthesia Kodagu institute of medical sciences Near G T Circle, Madikeri Karnataka India Pin code: 571201
Kodagu
KARNATAKA 
7892746957

raksharh6@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Kodagu institute of medical sciences Madikeri 571201  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  Nebulized dexmedetomidine 1 mcg/kg as premedication in attenuating the hemodynamic response to laryngoscopy and endotracheal intubation  Comparison of 1 mcg/kg nebulized dexmedetomidine as premedication in attenuating the hemodynamic response to laryngoscopy and endotracheal intubation. Patients will receive nebulized dexmedetomidine at a dose of 1 mcg/kg, diluted to 5 ml, administered over 10 minutes using an electric compressor nebulizer, 30 minutes prior to induction of general anesthesia. The effect of the intervention will be monitored until 10 minutes after endotracheal intubation. Thus, the total duration of intervention is approximately 40 minutes.  
Intervention  Nebulized dexmedetomidine 2 mcg/kg as premedication in attenuating the hemodynamic response to laryngoscopy and endotracheal intubation   Comparison of 2 mcg/kg nebulized dexmedetomidine as premedication in attenuating the hemodynamic response to laryngoscopy and endotracheal intubation. Patients will receive nebulized dexmedetomidine at a dose of 1 mcg/kg, diluted to 5 ml, administered over 10 minutes using an electric compressor nebulizer, 30 minutes prior to induction of general anesthesia. The effect of the intervention will be monitored until 10 minutes after endotracheal intubation. Thus, the total duration of intervention is approximately 40 minutes.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients undergoing elective surgeries under General Anaesthesia with endotracheal
intubation
2. Patients belonging to American society of anaesthesiologist (ASA) Physical status (PS) grade 1 and 2
3. Mallampati class 1 and 2 
 
ExclusionCriteria 
Details  1. Patients with anticipated difficult airway
2. Patients with history of allergic reaction to Dexmedetomidine
3. Patient taking medications that alters the heart rate such as Beta-blockers and Clonidine
4. Pregnant patients 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the changes in Mean arterial pressure (MAP) as a component of haemodynamic stress response to laryngoscope and intubation with two doses, 1 mcg/kg versus 2 mcg/kg of nebulised Dexmedetomidine  Post-intubation at 1 minute, 2 minutes, 3minutes, 4 minutes, 5 minutes, 6 minutes, 8 minutes and 10 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the dose sparing effect of nebulised Dexmedetomidine on the amount of Propofol used during induction of General anaesthesia.  Propofol induction
dose(mg/kg) during induction of general anaesthesia  
 
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)   22/09/2025 
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  
Endotracheal intubation is one of the methods of securing airway before performing surgical procedure requiring General Anaesthesia. The most commonly used equipment to aid endotracheal intubation is a laryngoscope, and the procedure performed is known as laryngoscopy.   Laryngoscopy and endotracheal intubation are noxious stimuli, associated with transient but significant hemodynamic changes, termed as pressor/hemodynamic response. Hemodynamic changes Starts within 1 minute lasting upto 10 minutes. Cardiovascular changes occur primarily through reflex response.  In Adults most  common response to Airway manipulation is hypertension and tachycardia mediated by  the cardioaccelerator nerves and sympathetic chain ganglia.
Various agents in the form of opioid analgesics, benzodiazepines, beta blockers, calcium channel blockers, and vasodilators  have been tried till now to attenuate the hemodynamic respone to Laryngoscopy and Endotracheal Intubation but none of them proved to be Ideal  
Dexmedetomidine is Dextro isomer and pharmacologically active component of Medetomidine , It an Alpha 2 Adrenergic agonist which inhibits Pontine ceruleus, an important noradrenergic nucleus mediating Sympathetic nervous system function, vigilance, memory, analgesia , arousal. Dexmedetomidine is used as an adjuvant for premedication, especially in patients susceptible to preoperative and perioperative stress because of its sedative, anxiolytic, analgesic, sympatholytic, and stable hemodynamic profile. Dexmedetomidine decreases oxygen consumption in intraoperative period (up to 8%) and in postoperative period (up to 17%), reduces the extent of myocardial ischemia during cardiac surgery. It also has respiratory-sparing effects.  Dexmedetomidine has been shown to provide good perioperative haemodynamic stability with decreased intraoperative opioid requirements. Dexmedetomidine  reduces sympathetic response to surgery by activating peripheral presynaptic α2- AR which reduces the release of catecholamines.      

Most common route of administration of Dexmedetomidine is Intravenous route but is associated with adverse effects such as Bradycardia and Hypotension, Other routes of administration include Intramuscular and Intranasal.  Nebulised Dexmedetomidine is a non invasive method, with good bioavailability ( nasal  mucosa accounts for 65 % and buccal mucosa accounts for  82% )and rapid absorption. Recent studies using nebulised Dexmedetomidine  suggested it to be a novel route of  Dexmedetomidine administration . Nebulised dexmedetomidine have been used in various studies to attenuate the intubation  stress  response. To the best of our knowledge limited studies are available comparing the  effects of  different  doses of  nebulised dexmedetomidine in attenuation of  haemodynamic stress response   
 
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