| CTRI Number |
CTRI/2025/02/081137 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Using dexmedetomidine as a mist before surgery to help keep the heart rate and blood pressure steady during intubation. |
|
Scientific Title of Study
|
evaluation of nebulised dexmedetomidine in blunting hemodynamic response to intubation -a prospective randomised 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 V A SABAPATHY |
| Designation |
Professor |
| Affiliation |
vinayaka missions medical college and hospitals,salem |
| Address |
room no 15,dept of anesthesia, vinayaka missions kirupanandha variyar medical college,salem
Salem
TAMIL NADU
636308
India |
| Phone |
9442566989 |
| Fax |
|
| Email |
sabapathyv.appavoo@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR V A SABAPATHY |
| Designation |
Professor |
| Affiliation |
vinayaka missions medical college and hospitals,salem |
| Address |
room no 15,dept of anesthesia, vinayaka missions kirupanandha variyar medical college,salem
TAMIL NADU
636308
India |
| Phone |
9442566989 |
| Fax |
|
| Email |
sabapathyv.appavoo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lakshmi A |
| Designation |
Post graduate |
| Affiliation |
vinayaka missions kirupanandha variyar medical college,salem |
| Address |
room number 13,dept of anesthesia, vinayaka missions kirupanandha variyar medical college,salem
Salem
TAMIL NADU
636308
India |
| Phone |
8547462368 |
| Fax |
|
| Email |
lakshmiambali@gmail.com |
|
|
Source of Monetary or Material Support
|
| vinayaka missions kirupananda variyar medical college and hospitals,Salem-636308 |
|
|
Primary Sponsor
|
| Name |
vinayaka missions kirupanadha variyar medical college and hospitals |
| Address |
chinnaseragapadi,salem-636308 |
| 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 |
| Dr lakshmi A |
vinayaka missions kirupanada variyar medical college and hospitals |
room no 15,dept of anaesthesia, salem, tamil nadu.
Salem
TAMIL NADU |
8547462368
lakshmiambali@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics comitte,VInayaka missions kirupanadha variyar medical college and hospitals,salem |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA 1 ,ASA 2 |
| Patients |
(1) ICD-10 Condition: Z768||Persons encountering health services in other specified circumstances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
5ML Normal saline nebulisation |
comparison of pre operative 1mcg/kg 5ml dexmedetomidne nebulisation and 5 ml normal saline nebulisation to blunt hemodynamic response. |
| Intervention |
nebulised dexmedetomidine |
pre operative dexmedetomidine nebulisation 1mcg/kg 5ml for blunting the hemodynamic responses of laryngoscopy and intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2
elective surgeries under general anaesthesia with endotracheal intubation
patient giving valid informed consent |
|
| ExclusionCriteria |
| Details |
1.asa 3 & 4
2.pregnancy
3.renal failure |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate the changes in MAP values after as a component of hemodynamic stress response to laryngoscopy and intubation with nebulised dexmedetomidine. |
15minutes to 30minutes |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 |
|
Date of First Enrollment (India)
|
03/03/2025 |
| 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 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
|
To evaluate the use of preoperative dexmedetomide nebulization 1mcg/kg 10min before induction to reduce the haemodynamic response to intubation
|