| CTRI Number |
CTRI/2025/06/089300 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
20/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Intravenous Versus Nebulized Dexmedetomidine for hemodynamic stability after intubation |
|
Scientific Title of Study
|
Comparison of Intravenous Versus Nebulized Dexmedetomidine for Attenuation of Laryngoscopy and Intubation-Induced Sympathoadrenal Stress Response-A Randomised, comparative clinical study
|
| 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 Bharat Parmar |
| Designation |
Resident doctor in department of anaesthesia |
| Affiliation |
Government medical College BARODA |
| Address |
Government medical College BARODA
Vadodara
Gujarat 390001
India
Vadodara
GUJARAT
390001
India |
| Phone |
9978292173 |
| Fax |
|
| Email |
drbharat740@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Darshna patel |
| Designation |
Associate professor |
| Affiliation |
Government medical College BARODA |
| Address |
Government medical College BARODA
Vadodara
Gujarat 390001
India
Vadodara
GUJARAT
390001
India |
| Phone |
9925013155 |
| Fax |
|
| Email |
dr.darshna1968@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Darshna patel |
| Designation |
Associate professor |
| Affiliation |
Government medical College BARODA |
| Address |
Government medical College BARODA
Vadodara
Gujarat 390001
India
Vadodara
GUJARAT
390001
India |
| Phone |
9925013155 |
| Fax |
|
| Email |
dr.darshna1968@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology Ssg Hospital, Vadodara 3900001, Gujarat |
|
|
Primary Sponsor
|
| Name |
Government medical College, BARODA |
| Address |
Department of anaesthesiology new surgical block, Ssg Hospital, Vadodara 390001, Gujarat, 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 Parmar Bharat |
Government medical College baroda |
Operation theatre
Second floor of OT block
SSG hospital
jail road vadodra
Vadodara
GUJARAT |
9978292173
drbharat740@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for biomedical and health research , government medical college Baroda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Effect of nebulized Dexmedetomidine for attenuation of laryngoscopy and intubation induced sympathoadrenal stress response |
Patients in the intervention group received dexmedetomidine via the nebulized route at a dose of one microgram per kg administered approximately ten minutes prior to induction of anesthesia The drug was diluted in normal saline to a total volume suitable for nebulization and delivered using a standard nebulizer mask system This route aims for noninvasive premedication with minimal hemodynamic instability while blunting the sympathoadrenal response to laryngoscopy and intubation |
| Comparator Agent |
Effect of intravenous for laryngoscopy and intubation induced sympathoadrenal street response |
Intravenous Dexmedetomidine patients in the comparator group receive Dexmedetomidine intravenous at a dose of one microgram par kg administered over ten minutes prior to induction of anaesthesia this is the standard route of administration known for its sympatholytic sedative and analgesics effects intravenously Dexmedetomidine and after that hemodynamic stability will be access |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
A) Patients posted for elective surgery under general anesthesia requiring endotracheal intubation
B) Age: 18- 60 years
C)Gender: Either gender
D)ASA I, II and III
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Dexmedetomidine allergy
Preoperative sore throat or upper respiratory infection
Significant cardiac pulmonary or hepatorenal disease
Body mass index more then thirty kg per meter swerve
Predictive difficult airway
Pregnant patient |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nebulized dexmedetomidine may provide a favourable alternative to intravenous route for attenuation of sympathoadrenal stress response to intubation |
Till 10 minutes after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Preventing post operative sore throat |
Post operative 24 hour |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/07/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 with muscle relaxant using control ventilation involve laryngoscopy and tracheal intubation increase in sympathetic activity noted during laryngoscopy and endotracheal incubation There is a necessity to Blunt this response to prevent deleterious effect like LVF MI increase ICP arrhythmia. highly selective dexmedetomidine can be used in prevent this effect Dexmedetomidine block release of catecholamines and inhibit sympathetic activity and decrease hemodynamic response to laryngoscopy and intubationNebulized dexmedetomidine may provide a favourable alternative to intravenous route for attenuation of sympathoadrenal stress response to intubation without any significant sideeffects with added advantage of preventing postoperative sore throat |