| CTRI Number |
CTRI/2024/10/075216 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
14/10/2024 |
| 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
|
A Comparative Study To attenuate stress response between intravenous dexmedetomidine and fentanyl. |
|
Scientific Title of Study
|
Comparison Between Intravenous Dexmedetomidine Versus Intravenous Fentanyl In Attenuating the Hemodynamic Responses to Direct Laryngoscopy and Intubation in Adult Patients Undergoing Elective Surgeries under General Anaesthesia: An Observational Study in a Tertiary Care Centre in Mandya |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Somsundar R G |
| Designation |
assistant professor |
| Affiliation |
Mandya institute of medical sciences |
| Address |
Dept of Anaesthesiology Mandya institute of medical sciences, Mandya,
Mandya
KARNATAKA
571401
India |
| Phone |
9686508877 |
| Fax |
|
| Email |
somurg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Somsundar R G |
| Designation |
assistant professor |
| Affiliation |
Mandya institute of medical sciences |
| Address |
Dept of Anaesthesiology Mandya institute of medical sciences, Mandya,
KARNATAKA
571401
India |
| Phone |
9686508877 |
| Fax |
|
| Email |
somurg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Somsundar R G |
| Designation |
assistant professor |
| Affiliation |
Mandya institute of medical sciences |
| Address |
Dept of Anaesthesiology Mandya institute of medical sciences, Mandya,
KARNATAKA
571401
India |
| Phone |
9686508877 |
| Fax |
|
| Email |
somurg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mandya Institute of Medical Sciences, Mandya pin-571401 |
|
|
Primary Sponsor
|
| Name |
Dr Somsundar R G |
| Address |
Dept of anaesthesiology mandya institute of medical sciences, mandya. Pin-571401 Karnataka, India. |
| 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 CHETHAN SATHYA B V |
Mandya Institute of medical sciences, Mandya |
department of anesthesiology,first floor,mandya institute of medical college
Mandya
KARNATAKA |
7026864923
bcsprime1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee mandya institute of medical sciences |
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 |
Dexmedetomidine |
In my study I will be dividing patients into two groups
Group D receives inj.dexmedetomidine and Group F receives Fentanyl
As dexmedetomidine causes bradycardia , during the study if it occurs atropine 0.6mg will be given intravenously to mitigate bradycardia |
| Intervention |
Fentanyl |
In my study group F patients will receive Fentanyl 2mcg/kg in some patients fentanyl can cause wooden chest it should be watched for and inj.Succinylcholine 1.5mg/kg will be given intravenously and airway will be secured by intubating. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are willing to give consent, patients requiring general anesthesia and intubation, |
|
| ExclusionCriteria |
| Details |
Patients ASA # and ASA 4,uncontrolled systemic disease, below 18 years, |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of two different drugs dexmedetomidine (0.5mcg/kg) and Fentanyl 2mcg/kg for attenuation of hemodynamic response to laryngoscopy and endotracheal intubation. |
Baseline, before induction, before intubation, 1min after incubation, 3min after incubation, 5min after incubation and 10min after incubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine drug dependent side effects like hypotension, and bradycardia between two different drugs. |
30mins |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/10/2024 |
| 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="0"
Months="6"
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
|
Endotracheal Intubation causes a noxious stimulus to patient which causes changes in hemodynamic changes in the patient which can cause arrythmias, cerebro vascular accidents, chances of myocardial infarction to the patient. purpose of my study is to mitigate this stress response caused due to intubation and to prevent undue complications to the patient and also to compare the efficacy of two drugs. |