| CTRI Number |
CTRI/2025/11/098069 [Registered on: 25/11/2025] Trial Registered Prospectively |
| Last Modified On: |
24/11/2025 |
| 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
|
A study comparing two medicines, dexmedetomidine and fentanyl, to control the rise in heart rate and blood pressure during tube insertion for anesthesia |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF DEXMEDITOMIDINE VERSUS FENTANYL FOR ATTENUATION OF HEMODYNAMIC RESPONSE TO LARYNGOSCOPY AND ENDOTRACHEAL 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 |
DR ARUN KUMAR B |
| Designation |
PROFESSOR |
| Affiliation |
Vinayaka missions Kirupanandha Variyar Medical College , Salem - 636308 |
| Address |
DEPARTMENT OF ANESTHESIA , VINAYAKA MISSIONS KIRUPANANDHA VARIYAR MEDICAL COLLEGE AND HOSPITAL , SALEM
Salem
TAMIL NADU
636308
India |
| Phone |
9840623673 |
| Fax |
|
| Email |
cruise2010.mmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ARUN KUMAR B |
| Designation |
PROFESSOR |
| Affiliation |
Vinayaka missions Kirupanandha Variyar Medical College , Salem - 636308 |
| Address |
DEPARTMENT OF ANESTHESIA , VINAYAKA MISSIONS KIRUPANANDHA VARIYAR MEDICAL COLLEGE AND HOSPITAL , SALEM
TAMIL NADU
636308
India |
| Phone |
9840623673 |
| Fax |
|
| Email |
cruise2010.mmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHRI HARINI K |
| Designation |
POSTGRADUATE |
| Affiliation |
Vinayaka missions Kirupanandha Variyar Medical College , Salem - 636308 |
| Address |
DEPARTMENT OF ANESTHESIA , VINAYAKA MISSIONS KIRUPANANDHA VARIYAR MEDICAL COLLEGE AND HOSPITAL , SALEM
Salem
TAMIL NADU
636308
India |
| Phone |
9629574742 |
| Fax |
|
| Email |
harini.kans@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka missions Kirupanandha Variyar Medical College and Hospitals |
|
|
Primary Sponsor
|
| Name |
Vinayaka missions Kirupanandha Variyar Medical College and Hospitals |
| Address |
Vinayaka missions Kirupanandha Variyar Medical College ,Chinnaseeragapadi, 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 SHRI HARINI K |
Vinayaka missions Kirupanandha Variyar Medical College , Chinnaseeragapadi,Salem - 636308 |
Department of Anesthesia,Vinayaka missions Kirupanandha Variyar Medical College ,Chinnaseeragapadi, Salem - 636308
Salem
TAMIL NADU |
9629574742
harini.kans@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| UNIVERSITY ETHICS COMMITEE VMRF-DU |
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 |
A COMPARATIVE STUDY OF DEXMEDITOMIDINE VERSUS FENTANYL FOR ATTENUATION OF HEMODYNAMIC RESPONSE TO LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION |
Name of comparator agent: Fentanyl
Type: Drug
Route of administration: Intravenous
Dose & schedule:
Fentanyl 2 µg/kg given as a slow IV injection over 2–3 minutes before laryngoscopy and endotracheal intubation.
Purpose: Standard practice for blunting the hemodynamic response to laryngoscopy and intubation. |
| Intervention |
A COMPARATIVE STUDY OF DEXMEDITOMIDINE VERSUS FENTANYL FOR ATTENUATION OF HEMODYNAMIC RESPONSE TO LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION |
Name of intervention: Dexmedetomidine
Type: Drug
Route of administration: Intravenous
Dose & schedule:
• Dexmedetomidine 0.5 µg/kg diluted and given as an IV infusion over 10 minutes before laryngoscopy and endotracheal intubation.
Purpose: To attenuate the hemodynamic response (changes in heart rate and blood pressure) during laryngoscopy and intubation |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS GIVING VALID INFORMED CONSENT
ASA GRADE 1 AND 2
AGE BETWEEN 20 TO 60 YEARS OF AGE
ELECTIVE SURGERIES UNDER GA |
|
| ExclusionCriteria |
| Details |
PATIENT REFUSAL
ASA GRADE 3 AND 4
AGE LESS THAN 20 AND MORE THAN 60
PREGNANCY
OBESITY
FULL STOMACH AND EMERGENCY SURGERY
PATIENTS SUFFERING FROM CARDIOVASCULAR DISEASES
PATIENTS WITH METABOLIC DISORDERS
PATIENS WITH DIFFICULT AIRWAY |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO STUDY THE COMPARISION OF DEXMEDITOMIDINE AND FENTANYL IN ATTENUATION OF HEMODYNAMIC RESPONSE TO LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION |
Hemodynamic parameters (HR, SBP, DBP, MAP) will be measured at:
1.Baseline (before study drug administration)
2.After study drug administration – just before induction
3.Before laryngoscopy and intubation (pre-intubation)
4.During laryngoscopy
5.Immediately after intubation (0 minute)
6.1 minute after intubation
7.3 minutes after intubation
8.5 minutes after intubation
9.10 minutes after intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO EVALUATE THE LEVEL OF ANALGESIA AND SEDATION IN THE POST OPERATIVE PERIOD |
UNTIL 24 HOURS POST SURGERY |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/12/2025 |
| 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="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
|
THIS IS A PROSPECTIVE RANDAMISED DOUBLE BLINDED STUDY. IT HAS A SAMPLE SIZE OF 60 PATIENTS ADMITTED FOR ELECTIVE SURGERIES UNDER GA . THE PRIMARY AIM OF THR STUDY IS TO COMPARE DEXMEDETOMISINE AND FENTANYL IN ATTENUATON OF HEMODYNAMIC RESPONSE TO LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION. THE SECONDARY OBJECTIVE OF THE STUDY IS TO COMPARE THE LEVEL OF ANALGESIA AND SEDATION IN THE POST OPERATIVE PERIOD OFR 24 HRS . |