| CTRI Number |
CTRI/2024/09/073465 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
05/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A Study to know Attenuation of Hemodynamic Stress Response To Laryngoscopy And Endotracheal Intubation With Two Different Doses of Injection Dexmedetomidine |
|
Scientific Title of Study
|
Attenuation of Haemodynamic Responses to Laryngoscopy and Endotracheal Intubation with Intravenous Dexmedetomidine between two Doses : A Randomized Double Blind Prospective 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 |
Chethan P L |
| Designation |
Junior Resident |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Anesthesia Department, Ground Floor,Sapthagiri Institute of Medical Sciences and Research Centre, Navy Layout, Hesaraghatta Main Road, Chikkabanavara,
Bangalore
KARNATAKA 560090
India
Bangalore
KARNATAKA
560090
India |
| Phone |
9591688440 |
| Fax |
|
| Email |
sphere.chethan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nikila D G |
| Designation |
Associate professor |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Anesthesia Department, Ground Floor,Sapthagiri Institute of Medical Sciences and Research Centre, Navy Layout, Hesaraghatta Main Road, Chikkabanavara,
Bangalore
KARNATAKA 560090
India
Bangalore
KARNATAKA
560090
India |
| Phone |
9535243669 |
| Fax |
|
| Email |
nikiladg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shruthi N S |
| Designation |
Assistant professor |
| Affiliation |
Sapthagiri Institute of Medical Sciences and Research Centre |
| Address |
Anesthesia Department, Ground Floor,Sapthagiri Institute of Medical Sciences and Research Centre, Navy Layout, Hesaraghatta Main Road, Chikkabanavara,
Bangalore
KARNATAKA 560090
India
Bangalore
KARNATAKA
560090
India |
| Phone |
9480394128 |
| Fax |
|
| Email |
shruthi.m.srinivas@gmail.com |
|
|
Source of Monetary or Material Support
|
| sapthagiri institute of medical sciences and research centre
15, Hesarghatta Rd, Navy Layout, Chikkasandra, Chikkabanavara, Bengaluru - 560090
Karnataka
INDIA |
|
|
Primary Sponsor
|
| Name |
Sapthagiri Institute Of Medical Sciences and Research Centre |
| Address |
15, Hesarghatta Rd, Navy Layout, Chikkasandra, Chikkabanavara, Bengaluru-560090 , Karnataka , INDIA |
| 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 |
| DrChethan P L |
Sapthagiri Institute of Medical Sciences and Research Centre |
Department of anaesthesia
#15 Hesaraghatta main road ,chikkabanavara , Bangalore-90
KARNATAKA , INDIA
Bangalore
KARNATAKA |
9591688440
sphere.chethan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sapthagiri Institute of medical sciences and research Center |
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 |
INJ.Dexmedetomidine |
INJ.Dexmedetomidine 0.3mcg/kg intravenous diluted to 20 ml with normal saline will be given over 10 min |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists Physical Status 1
Patient posted for elective surgeries under general anesthesia |
|
| ExclusionCriteria |
| Details |
Patient who were physically dependent on narcotics, those with a history of bronchial asthma, drug or alcohol abuse, known drug allergy to either clonidine or dexmedetomidine.
Any predicted difficult airway. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HR and NIBP are more stable following laryngoscopy and intubation with Inj.Dexmedetomidine 0.5% |
parameters recorded will be HR, SBP, DBP and MAP at 1, 3 and 5 min after intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compare the adverse effect & complication of the drug & their doses like hypotension & bradycardia. |
During drug infusion hemodynamics monitoring for 10 minutes |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
20/09/2024 |
| 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="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
|
The augmented cardiovascular reflexes in the form of tachycardia and hypertension brought about by the noxious stimulus of laryngoscopy and intubation can prove to be detrimental for patients with cardiovascular and cerebrovascular diseases.This study was undertaken with different doses of dexmedetomidine and comparing it with two different doses to arrive at an optimal dose of dexmedetomidine for attenuation of stress response to laryngoscopy and endotracheal intubation. Inj.Dexmedetomidine has been studied by few authors in a dose of 0.75 , 0.5 and 1mcg/kg. No study has been done to see the efficacy of dexmedetomidine in a dose of 0.3mcg/kg for attenuation of laryngoscopy and intubation response. Hence, in this study, we chose to include injection dexmedetomidine in a dose of 0.3 and 0.5 mcg/kg and compare for attenuation of laryngoscopy and intubation response. |