| CTRI Number |
CTRI/2024/11/077341 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
21/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of nebulised dexmedetomidine versus nebulised lignocaine in attenuation of pressor response to laryngoscopy and endotracheal intubation |
|
Scientific Title of Study
|
Comparison of nebulised dexmedetomidine versus nebulised lignocaine in reducing of hemodynamic response to laryngoscopy and endotracheal intubation |
| Trial Acronym |
Nebulised dexmed |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Sowmyasp |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sowmya S P |
| Designation |
Post graduate medical student |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of anaesthesiology, Bangalore medical college and research institute, K R market, Bangalore, Karnataka
Bangalore
KARNATAKA
560002
India |
| Phone |
8792213141 |
| Fax |
|
| Email |
sowmyasp262@mail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sowmya S P |
| Designation |
Post graduate medical student |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of anaesthesiology, Bangalore medical college and research institute, K R market, Bangalore, Karnataka
KARNATAKA
560002
India |
| Phone |
8792213141 |
| Fax |
|
| Email |
sowmyasp262@mail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhargavi Sanket |
| Designation |
Assistant Professor |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of anaesthesiology, Bangalore medical college and research institute, K R market, Bangalore, Karnataka
Bangalore
KARNATAKA
560002
India |
| Phone |
9886843423 |
| Fax |
|
| Email |
bhargavi_doc@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Hospitals attached to Bangalore medical college and research institute |
|
|
Primary Sponsor
|
| Name |
Dr Sowmya S P |
| Address |
Department of anaesthesiology, Bangalore medical college and research institute, K R market, Bangalore, Karnataka |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Bhargavi Sanket |
Department of anaesthesiology, Bangalore medical college and research institute, K R market, Bangalore, Karnataka |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sowmya S P |
Hospital attached to Bangalore medical and research institute |
Department of anaesthesiology, Bangalore medical college and research institute, K R market, Bangalore, Karnataka
Bangalore
KARNATAKA |
8792213141
sowmyasp262@mail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
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 |
Airway block |
We compare airway block with nebulised dexmedetomidine in reducing intubation response |
| Comparator Agent |
Nebulised dexmedetomidine |
We compare airway block with nebulised dexmedetomidine in reducing intubation response |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
ASAI, II, patients willing to give consent, posted for elective surgery under general anaesthesia with endotracheal intubation |
|
| ExclusionCriteria |
| Details |
Allergy to drugs , systemic diseases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of both drug in reducing hemodynamic response |
Effect of both drug in reducing hemodynamic response |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To look for side effects associated with both the drugs |
Like cough, numbness of throat and bradycardia in postoperative period |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
17/12/2024 |
| 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="0"
Months="0"
Days="30" |
|
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
|
It’s noninvasive study to compare nebulised dexmedetomidine with proven drug nebulised lignocaine in attenuation of intubation response |