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CTRI Number  CTRI/2025/09/094846 [Registered on: 16/09/2025] Trial Registered Prospectively
Last Modified On: 15/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Nebulized and Intranasal Dexmedetomidine with Saline to Reduce Stress Response During Intubation in Adults Undergoing Surgery 
Scientific Title of Study   Evaluation of Nebulized Dexmedetomidine, Intranasal Dexmedetomidine and Nebulized Saline given pre-operatively to blunt intubation response during adult endotracheal intubation – A Randomized control trial. 
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 Anitha Prashanth 
Designation  Senior Consultant in Anaesthesia 
Affiliation  Fortis Hospitals Limited 
Address  Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore
Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore
Bangalore
KARNATAKA
560076
India 
Phone  9900107837  
Fax    
Email  anithaprashanth16@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anitha Prashanth 
Designation  Senior Consultant in Anaesthesia 
Affiliation  Fortis Hospitals Limited 
Address  Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore
Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore

KARNATAKA
560076
India 
Phone  9900107837  
Fax    
Email  anithaprashanth16@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anitha Prashanth 
Designation  Senior Consultant in Anaesthesia 
Affiliation  Fortis Hospitals Limited 
Address  Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore
Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore

KARNATAKA
560076
India 
Phone  9900107837  
Fax    
Email  anithaprashanth16@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Academic Investigator Initiated Project 
Address  Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore 
Type of Sponsor  Private hospital/clinic 
 
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 Anitha Prashanth  Fortis Hospitals Limited  Department Of Anaesthesia Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore
Bangalore
KARNATAKA 
9900107837

anithaprashanth16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Fortis Hospital Institutional Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dexmedetomidine intranasal spray   Administer intranasal spray of dexmedetomidine (1 µg/kg) in the pre-operative holding area. 
Intervention  Dexmedetomidine nebulization  Nebulize 1 µg/kg dexmedetomidine added to 4ml saline for nebulization in the preoperative holding area. 
Comparator Agent  Saline nebulization group   4ml saline nebulization in the preoperative holding area.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adult patients aged 18-65, falling under ASA category 1 and 2 who will be undergoing elective surgery requiring endotracheal intubation as part of general anaesthesia will form the study population.

 
 
ExclusionCriteria 
Details  Known allergy to dexmedetomidine
Hypertensive patients on betablockers
Severe cardiovascular, hepatic, or renal disease
Pregnancy or lactation
History of difficult intubation

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the haemodynamic parameters, post induction in patients receiving either nebulized dexmedetomidine, intranasal dexmedetomidine or nebulized saline.  At the end of study duration data will be collected study duration 12 months  
 
Secondary Outcome  
Outcome  TimePoints 
To assess the change in requirement of propofol for induction in patients receiving dexmedetomidine.  At the end of study duration data will be collected study duration 12 months  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   26/09/2025 
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="0"
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  

General anaesthesia is associated with haemodynamic responses which manifests as elevated heart rate and blood pressure. This occurs during direct laryngoscopy and intubation considered to be due to sympathetic stimulation. Although it lasts for a few seconds it may persist up to 10 minutes.

 

These short-term haemodynamic changes usually result in little to no harm in healthy individuals. However, they may be detrimental to patients with reactive airways, hypertension, cerebrovascular diseases, coronary artery disease and myocardial insufficiency. Hence, numerous drugs have been studied and used to attenuate these responses in the past, namely intravenous opioids, beta blockers, lignocaine etc.

 

One drug which has shown promise in this regard is Dexmedetomidine, which is a highly selective alpha-2 agonist with sympatholytic, sedative, amnesic and analgesic actions. Dexmedetomidine has been studied in several dosages and routes, namely intravenous, nebulized, intramuscular and intranasal in order to attenuate pressor response in both adult and paediatric population.

 

Nebulized dexmedetomidine has been shown to have high bioavailability (approximately 65% in nasal mucosa and 82% in buccal mucosa). It has also been theorized to be safer than intravenous and intranasal routes, since intravenous dexmedetomidine is associated with hypotension and bradycardia.

Hence, we undertook this trial of nebulization and intranasal administration of dexmedetomidine and attenuation of hemodynamic response to laryngoscopy and intubation.

 

 

 

 
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