| CTRI Number |
CTRI/2025/11/097139 [Registered on: 10/11/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
This study compares how well dexmedetomidine works when given through the nose versus through a vein to control the rise in heart rate and blood pressure that happens during laryngoscopy and tube insertion in patients who are under general anaesthesia. |
|
Scientific Title of Study
|
A clinical study comparing effectiveness of intranasal versus intravenous dexmedetomidine for attenuation of hemodynamic responses of laryngoscopy and endotracheal intubation n patients 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 |
PAVANKUMAR S HANDRAL |
| Designation |
Junior Resident |
| Affiliation |
Subharti Medical College |
| Address |
Dept of Anaesthesiology and critical care medicine, Chatrapati shivaji Subharti hospital, Subharti university, Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9036342112 |
| Fax |
|
| Email |
pavanhandral55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR.MANORANJAN KR BANSAL |
| Designation |
PROFESSOR |
| Affiliation |
Subharti Medical College |
| Address |
Dept of Anaesthesiology and critical care medicine, Chatrapati shivaji Subharti hospital, Subharti university, Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7500693131 |
| Fax |
|
| Email |
dr.manojbansal7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PAVANKUMAR S HANDRAL |
| Designation |
Junior Resident |
| Affiliation |
Subharti Medical College |
| Address |
Dept of Anaesthesiology and critical care medicine, Chatrapati shivaji Subharti hospital, Subharti university, Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9036342112 |
| Fax |
|
| Email |
pavanhandral55@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chatrapati Shivaji Subharti Hospital, Subharti University, Meerut-250005, India. |
|
|
Primary Sponsor
|
| Name |
Chatrapati Shivaji Subharti Hospital |
| Address |
Subharti University, Meerut, India-250005 |
| Type of Sponsor |
Private 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 |
| DRPAVANKUMAR S HANDRAL |
Chhatrapati Shivaji Subharti Hospital |
OT complex, Dept of Anaesthesiology and Critical Care.
Meerut
UTTAR PRADESH |
9036342112
pavanhandral55@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| UNIVERSITY ETHICS COMMITTEE(MEDICAL) |
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 |
| Intervention |
Intranasal Dexmedetomidine |
inj. Dexmedetomidine 1mcg per kg given intranasally |
| Comparator Agent |
Intravenous Dexmedetomidine |
Inj. Dexmedetomidine 0.5 mcg per kg given intravenously |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA (American Society of Anesthesiologists) grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
Patient refused to participate
Patient with known allergy and hypersensitivity to study drug |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
MAP (Mean arterial pressure)
Heart Rate
Systolic Blood Pressure
Diastolic Blood Pressure |
Baseline,10 minute, 20 minute, 30 minute, 40 minute, At Induction, At laryngoscope and Intubation, 1minute, 2 minute, 3minute, 4 minute, 7 minute, 10 minute. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post-operative sedation(Ramsay sedation score) |
Baseline, At Intubation, 1 Hour, 2 Hour, 4 Hour, 6 Hour. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
There are many literature regarding intravenous dexmedetomidine in attenuating the response to laryngoscopy and intubation but there is a lack of enough literature regarding intranasal use of dexmedetomidine for attenuation of response to laryngoscopy and intubation. Intranasal route is helpful preferred as it avoids needle anxiety and semi invasive. |