| 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
|
|
|
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
|
|
|
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
|
|
|
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.
|