| CTRI Number |
CTRI/2026/03/105132 [Registered on: 02/03/2026] Trial Registered Prospectively |
| Last Modified On: |
28/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Two Nasal Medications (Dexmedetomidine and Clonidine) Given Before Anaesthesia to Control Heart Rate and Blood Pressure in Patients Undergoing Surgery. |
|
Scientific Title of Study
|
A comparative study of intranasal dexmedetomidine and clonidine using a mucosal atomisation device on hemodynamic response t laryngoscopy during 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 |
Anju Merine Sebastian |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Dr. D. Y. PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, PIMPRI, PUNE |
| Address |
Department of Anaesthesia , 5th floor, high tech building, Dr. D. Y. PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
7907396835 |
| Fax |
|
| Email |
anjumerinesebastian@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonal Khatavkar |
| Designation |
Professor |
| Affiliation |
Dr. D. Y. PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, PIMPRI, PUNE |
| Address |
Department of Anaesthesia , 5th floor, high tech building, Dr. D. Y. PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9820434472 |
| Fax |
|
| Email |
ksonal0711@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonal Khatvkar |
| Designation |
Professor |
| Affiliation |
Dr. D. Y. PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, PIMPRI, PUNE |
| Address |
Department of Anaesthesia , 5th floor, high tech building, Dr. D. Y. PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9820434472 |
| Fax |
|
| Email |
ksonal0711@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Anju Merine Sebastian |
| Address |
Department of Anaesthesia , 5th floor, high tech building, Dr. D. Y. PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, Sant Tukaram Nagar, Pimpri, Pune |
| Type of Sponsor |
Other [self] |
|
|
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 ANJU MERINE SEBASTIAN |
Dr. D. Y. PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, PIMPRI, PUNE |
Department of anesthesia, 5th floor, Hi-tech buuilding, Dr. D Y Patil medical college, hospital and reseach centre
Sant tukaram nagar, pimpri, pune 411018
Pune
MAHARASHTRA |
7907396835
anjumerinesebastian@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics sub-commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CLONIDINE |
intranasal clonidine (3 mcg/kg) administered evenly into both nostrils via a mucosal atomisation device (MAD), with a maximum volume of 0.5ml per nostril, 45 minutes before laryngoscopy. |
| Intervention |
dexmedetomidine |
The intranasal dexmedetomidine (1mcg/kg) was administered evenly into both nostrils using a Mucosal Atomization Device (MAD), with a maximum volume of 0.5 mL per nostril 45 min prior to laryngoscopy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
18-60 years aged patients
BMI 20-35 kg/m2
ASA I – II
Availability of written informed consent
Hemodynamically stable patients with all routine investigations within normal limits.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the efficacy and safety of intranasal dexmedetomidine versus clonidine in controlling peri-intubation hemodynamic responses and providing adequate preoperative sedation. |
T0- baseline vitals before instillation of study drug
T1- 10 min after instillation of study drug
T2- 20 min after instillation of study drug
T3- 30 min after instillation of study drug
T4- 45 min after instillation of study drug
T5 –at the time of laryngoscopy and intubation
T6- 1 min after intubation
T7- 3 min after intubation
T8- 5 min after intubation
T9- 10 min after intubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
22/03/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective, randomized, double-blind, two-arm parallel clinical trial aims to compare the efficacy and safety of intranasal dexmedetomidine and intranasal clonidine, administered via mucosal atomization device, in attenuating the hemodynamic response to laryngoscopy and endotracheal intubation in adult patients undergoing elective surgery under general anaesthesia. A total of 76 ASA I–II patients aged 18–60 years will be randomly allocated into two groups to receive either intranasal clonidine (3 mcg/kg) or intranasal dexmedetomidine (1 mcg/kg) 45 minutes prior to induction of anaesthesia. Hemodynamic parameters including heart rate and mean arterial pressure will be recorded at predefined intervals before and after intubation. Sedation will be assessed using Ramsay Sedation Score. The primary outcome is the change in mean arterial pressure at 1 minute after intubation compared to baseline. Secondary outcomes include heart rate changes, sedation profile, and incidence of adverse events. The study aims to determine the superior intranasal alpha-2 agonist for blunting the pressor response while maintaining hemodynamic stability and safety. |