| CTRI Number |
CTRI/2024/10/074566 [Registered on: 01/10/2024] Trial Registered Prospectively |
| Last Modified On: |
27/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Intravenous versus intranasal dexmedetomidine for suppression of stress response to laryngoscopy and intubation |
|
Scientific Title of Study
|
Comparison of intravenous and intranasal dexmedetomidine for attenuation of stress response to laryngoscopy and intubation |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ratna Saikia |
| Designation |
Post graduate |
| Affiliation |
ESIC medical college & PGIMSR, Rajajinagar, Bangalore |
| Address |
Major operation theatre complex, Department of Anaesthesiology, ESIC medical college & PGIMSR, Rajajinagar, Bangalore
Bangalore
KARNATAKA
560010
India |
| Phone |
8147171124 |
| Fax |
|
| Email |
ratna.saikia38@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepak R |
| Designation |
Associate professor |
| Affiliation |
ESIC medical college & PGIMSR, Rajajinagar, Bangalore |
| Address |
Major operation theatre complex, Department of Anesthesiology, ESIC medical college & PGIMSR, Rajajinagar, Bangalore
Bangalore
KARNATAKA
560010
India |
| Phone |
8088917782 |
| Fax |
|
| Email |
deepakrkarnataka@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepak R |
| Designation |
Associate professor |
| Affiliation |
ESIC medical college & PGIMSR, Rajajinagar, Bangalore |
| Address |
Major operation theatre complex, Department of Anesthesiology, ESIC medical college & PGIMSR, Rajajinagar, Bangalore
Bangalore
KARNATAKA
560010
India |
| Phone |
8088917782 |
| Fax |
|
| Email |
deepakrkarnataka@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC MEDICAL COLLEGE AND PGIMSR RAJAJINAGAR BANGALORE 560010 |
|
|
Primary Sponsor
|
| Name |
Dr Ratna Saikia |
| Address |
ESIC medical college & PGIMSR, Rajajinagar, Bangalore, India, Pincode 560010 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Ratna Saikia |
ESIC medical college & PGIMSR, Rajajinagar, Banagalore |
Major operation theatre, Department of Anesthesiology, ESIC medical college & PGIMSR, Rajajinagar, Bangalore
Bangalore
KARNATAKA |
8147171124
ratna.saikia38@gmail.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 |
| Comparator Agent |
comparison of intravenous and intranasal dexmedetomidine for blunting stress response to laryngoscopy and intubation |
Measurement of heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure at baseline, at induction, at intubation and at every minute post intubation for 10 minutes |
| Intervention |
Intravenous and intranasal dexmedetomidine administration |
Administration of intravenous dexmedetomidine 0.5 microgram per kg administration over 10 minutes, 10 minutes prior to induction of anesthesia.
Administration of intranasal dexmedetomidine 1 microgram per kg, 40 minutes prior to induction of anesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 patients posted for elective surgery under general anesthesia with endotracheal intubation |
|
| ExclusionCriteria |
| Details |
emergency surgery, allergy to dexmedetomidine, heart rate less than 60 beats, heart block |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Heart rate, systolic and diastolic blood pressure, mean arterial pressure |
Baseline,induction,intubation and every minute there after till ten minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Monitor for hypotension, bradycardia, respiratory depression |
From baseline until ten minutes of drug administration |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
09/10/2024 |
| 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="1"
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
|
STUDY COMPARING THE BLUNTING OF HEMODYNAMIC RESPONSE TO LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION IN PATIENTS POSTED FOR ELECTIVE SURGERIES UNDER GENERAL ANAESTHESIA IN ESIC MEDICAL COLLEGE AND PGIMSR RAJAJINAGAR BANGALORE,INDIA, BY MEASUREMENT OF HEART RATE ,SYSTOLIC AND DIASTOLIC BLOOD PRESSURE AND MEAN ARTERIAL PRESSURE AT VARIOUS TI,E INTERVALS |