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
|
|
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
|
|
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm (Non Ayurveda) | | - | Nebulisation with Dexmedetomidine ,nebulisation with normal saline | Study 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%. |