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CTRI Number  CTRI/2025/04/085416 [Registered on: 23/04/2025] Trial Registered Prospectively
Last Modified On: 27/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   This study looks at using a medication called dexmedetomidine in a nebulizer to help the patient to relax and reduce heart rate and blood pressure changes during laryngoscopy and intubation 
Scientific Title of Study   Evaluation of nebulised Dexmedetomidine to attenuate 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 Nishchitha Reddy S V 
Designation  Junior Resident in Department of Anesthesiology 
Affiliation  Gandhi Medical College, Bhopal 
Address  Operation theatre, 2nd floor,Department of anesthesiology, Gandhi medical college, Bhopal,462001,India

Bhopal
MADHYA PRADESH
462001
India 
Phone  08618428987  
Fax    
Email  svnishchithareddy@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Deepesh Gupta 
Designation  Professor 
Affiliation  Gandhi Medical College, Bhopal 
Address  Operation theatre, 2nd floor,Department of anesthesiology, Gandhi medical college, Bhopal,462001,India

Bhopal
MADHYA PRADESH
462001
India 
Phone  9826842567  
Fax    
Email  deepeshg25@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jyotsna Kubre 
Designation  Assistant Professor 
Affiliation  Gandhi Medical College, Bhopal 
Address  Operation theatre, 2nd floor,Department of anesthesiology, Gandhi medical college,Bhopal,462001,India

Bhopal
MADHYA PRADESH
462001
India 
Phone  8982861285  
Fax    
Email  soniyakubre@gmail.com  
 
Source of Monetary or Material Support  
Gandhi Medical college ,Bhopal,462001,India 
 
Primary Sponsor  
Name  Gandhi medical college 
Address  Gandhi Medical College, Bhopal,462001,India 
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 
Dr Nishchitha Reddy SV  Hamidia Hospital  Operation theatre, 2nd floor,Department of anesthesiology, Gandhi medical college, Bhopal,462001,India
Bhopal
MADHYA PRADESH 
8618428987

Svnishchithareddy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy human volunteers posted for elective surgeries belong to ASA grade I AND II 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Nebulisation with Dexmedetomidine ,nebulisation with normal salineStudy is to evaluate the outcome of nebulised Dexmedetomidine given pre- operatively to attenuate Hemodynamic response to laryngoscopy and Endotracheal intubation.
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of ASA grade I and ASA grade II
Age group 20 - 60 years
MPG I and II
BMI less than 35
 
 
ExclusionCriteria 
Details  Patient refusal
Patients requiring more than 15 seconds for intubation or more than 1 attempts of Laryngoscopy
Patients taking medicines that affect the heart rate such as clonidine,beta –blockers
Patients undergoing emergency surgeries will be excluded from the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of nebulised Dexmedetomidine given pre- operatively to attenuate Hemodynamic response to laryngoscopy and Endotracheal intubation.  Before laryngoscopy,After laryngoscopy,1 min,5 min,10 min After intubation 
 
Secondary Outcome  
Outcome  TimePoints 
To calculate total amount of Propofol used during induction of General Anesthesia & Fentanyl during surgery  For Propfol at baseline & for Fentanyl after 1 hr to end of surgery 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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)   02/05/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  
Dexmedetomidine in various doses and routes has been studied such as intravenous, intranasal, intramuscular to decrease the hemodynamic response to laryngoscopy and Endotracheal intubation.
However,intravenous administration may cause bradycardia and hypotension and intranasal administration may be associated with irritation. 
This studt is about how  Nebulised Dexmedetomidine may offer an alternative to both intravenous as well as intranasal routes of administration,since the drug deposition following nebulization takes place over nasal, buccal as well as respiratory mucosa.  The nasal mucosa accounts for 65% of the bioavailability of nebulised Dexmedetomidine,while buccal mucosa accounts for 82%. 
 
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