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CTRI Number  CTRI/2025/11/096951 [Registered on: 06/11/2025] Trial Registered Prospectively
Last Modified On: 05/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study comparing Intravenous and nebulised dexmedetomidine to reduce stress during intubation and sore throat after surgery under general anaesthesia: A Randomised Study 
Scientific Title of Study   A Randomised prospective study to see the comparison of Intravenous versus nebulised dexmedetomidine for intubation induced sympathoadrenal stress response & post operative sore throat attenuation in patient undergoing 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  DrVeena Patodi 
Designation  Senior professor  
Affiliation  JLN medical college & hospital  
Address  Department of Anaesthesia JLN medical college & hospital Ajmer

Ajmer
RAJASTHAN
305001
India 
Phone  9414008276  
Fax    
Email  veenapatodi@gmaiil.com  
 
Details of Contact Person
Scientific Query
 
Name  DrVeena Patodi 
Designation  Senior professor  
Affiliation  JLN medical college & hospital  
Address  Department of Anaesthesia JLN medical college & hospital Ajmer

Ajmer
RAJASTHAN
305001
India 
Phone  9414008276  
Fax    
Email  veenapatodi@gmaiil.com  
 
Details of Contact Person
Public Query
 
Name  DrVeena Patodi 
Designation  Senior professor  
Affiliation  JLN medical college & hospital  
Address  Department of Anaesthesia JLN medical college & hospital Ajmer

Ajmer
RAJASTHAN
305001
India 
Phone  9414008276  
Fax    
Email  veenapatodi@gmaiil.com  
 
Source of Monetary or Material Support  
Department of anesthesiology jln medical college and hospital ajmer 305001 
 
Primary Sponsor  
Name  Department of Anaesthesiology first floor new ot JLN medical college hospital  
Address  KALA BAGH AJMER 
Type of Sponsor  Government 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 
Riya Singh Pangaty  JLN medical college and hospital, Ajmer  First floor department of anaesthesiology jln medical college & hospital
Ajmer
RAJASTHAN 
8240969307

pangaty546@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: PCS||, (2) ICD-10 Condition: PCS||,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intravenous dexmedetomidine infusion 1microgram/kg over 10 minutes  To evaluate the haemodynamic response in one group during endotracheal intubation after using 1microgram/kg over 10 minutes dexmedetomidine  
Comparator Agent  Nebulised dexmed 1microgram/kg in 3-4 ml of 0.9% saline  To evaluate the haemodynamic response during endotracheal intubation after using neblulized dexmedetomidine 1microgram/kg in 3-4 ml of 0.9% saline 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA 1&2
Mallampati 1 and 2
Age 18-60 yrs 
 
ExclusionCriteria 
Details  ASA 3 and above
Mallampati 3 and 4
Allergic to drug
Obese 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To see haemodynamic response
During endotracheal intubation using iv and nebulised dexmedetomidine and compare efficacy in blunting the symapathoadrenal response. 
To see haemodynamic response
During endotracheal intubation using iv and nebulised dexmedetomidine and compare efficacy in blunting the symapathoadrenal response 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate 24 hr analgesic consumption in both groups,
To compare the postoperative sore throat  
To evaluate 24 hr analgesic consumption in both groups,
To compare the postoperative sore throat in 24 hours 
 
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)   20/11/2025 
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 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   Comparison of Intravenous versus Nebulised Dexmedetomidine for Intubation Induced Sympathoadrenal Stress Response and Postoperative Sore Throat Attenuation in Patients Undergoing General Anaesthesia

Objective

Primary Objective
To compare haemodynamic responses to intubation between intravenous and nebulised dexmedetomidine

Secondary Objectives
To evaluate postoperative sore throat incidence
To assess 24 hour analgesic requirements
To monitor postoperative sedation levels using RASS
To observe and compare any side effects


Study Design

Type
Hospital based randomised double blind prospective study

Sample Size
100 patients divided into two groups
Group D Intravenous dexmedetomidine
Group N Nebulised dexmedetomidine

Study Duration
Till completion of sample size after ethics approval


Inclusion Criteria

ASA physical status I and II
Age between 18 and 60 years
Normal airway
Consent for general anaesthesia

Exclusion Criteria

ASA status III or above
Difficult airway
Obesity
Known cardiac respiratory or neurological disease
Allergy to study drugs
Refusal to participate


Methodology

Patients randomly assigned to two groups
Group D receives intravenous dexmedetomidine 1 microgram per kg over 10 minutes
Group N receives nebulised dexmedetomidine 1 microgram per kg in normal saline
Monitoring of HR BP MAP SpO2 and RASS scores pre and post intubation
Assessment of postoperative sore throat and analgesic requirement up to 24 hours


Analysis

Data analyzed using SPSS software
Statistical tests include t test chi square and ANOVA
P value less than 0 point 05 considered significant


Ethical Approval

Study will be conducted after approval from Institutional Ethics Committee
Written informed consent will be taken from all participants
Study drug is FDA approved and used under supervision

 
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