| CTRI Number |
CTRI/2021/04/032962 [Registered on: 20/04/2021] Trial Registered Prospectively |
| Last Modified On: |
03/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical trial comparing effects of Anaesthetic induction agents on Heart Function |
|
Scientific Title of Study
|
COMPARISON OF EFFECTS OF GENERAL ANAESTHESIA INDUCTION WITH THIOPENTONE-FENTANYL AND PROPOFOL-FENTANYL COMBINATIONS ON LEFT VENTRICULAR FUNCTION ASSESSED BY TRANSTHORACIC ECHOCARDIOGRAPHY: A ONE YEAR RANDOMISED CLINICAL TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohit Bohra |
| Designation |
PG Student |
| Affiliation |
Department of Anaesthesiology KLEs JN Medical College and Dr Prabhakar Kore Charitable Hospital |
| Address |
Department of Anaesthesiology KLEs JN Medical College and Dr Prabhakar Kore Charitable Hospital Nehru Nagar Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9810331560 |
| Fax |
|
| Email |
dr.rohitbohra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjunath C Patil |
| Designation |
Professor |
| Affiliation |
Department of Anaesthesiology KLEs JN Medical College and Dr Prabhakar Kore Charitable Hospital |
| Address |
Department of Anaesthesiology KLEs JN Medical College and Dr Prabhakar Kore Charitable Hospital Nehru Nagar Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
|
| Fax |
|
| Email |
mcpatil52@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rohit Bohra |
| Designation |
PG Student |
| Affiliation |
Department of Anaesthesiology KLEs JN Medical College and Dr Prabhakar Kore Charitable Hospital |
| Address |
Department of Anaesthesiology KLEs JN Medical College and Dr Prabhakar Kore Charitable Hospital Nehru Nagar Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9810331560 |
| Fax |
|
| Email |
dr.rohitbohra@gmail.com |
|
|
Source of Monetary or Material Support
|
| No Monetary Support Required |
|
|
Primary Sponsor
|
| Name |
KLEs JN Medical College and Dr Prabhakar Kore Charitable Hospital |
| Address |
KLEs JN Medical College and Dr Prabhakar Kore Charitable Hospital
Nehru Nagar
Belagavi 590010
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 |
| Dr Rohit Bohra |
KLEs JN Medical College and Dr Prabhakar Kore Charitable Hospital |
Department of Anaestheiology KLEs JN Medical College and Dr Prabhakar Kore Charitable Hospital Nehru Nagar
Belagavi 590010
Belgaum
KARNATAKA |
9810331560
dr.rohitbohra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMCInstitutional Ethics Committee on Human Subjects Research |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Propofol-Fentanyl |
Inj. Propofol 2mg/kg IV Bolus
Inj. Fentanyl 2 mcg/kg IV Bolus
Both given as part of GA induction and their effect on Left Ventricular Function measured with Echocardiography |
| Comparator Agent |
Thiopentone-Fentanyl |
Inj. Thiopentone 5mg/kg IV Bolus
Inj. Fentanyl 2 mcg/kg IV Bolus
Both given as part of GA induction and their effect on Left Ventricular Function measured with Echocardiography |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists physical status I and II.
Age between 18 to 60 years.
Patients undergoing elective surgeries under general anaesthesia.
Provides Consent
|
|
| ExclusionCriteria |
| Details |
Patient undergoing emergency surgery.
Patient who are unable or unwilling to give consent.
Patients who do not fulfil inclusion criteria.
Pre-existing cardiac diseases (Ischaemic Heart Disease, valvular and congenital heart diseases)
Pregnant Females
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO ASSESS THE EFFECTS OF THIOPENTONE-FENTANYL VS. PROPOFOL-FENTANYL ON LEFT VENTRICULAR SYSTOLIC FUNCTION IN PATIENTS UNDERGOING NON-CARDIAC SURGERIES UNDER GENERAL ANAESTHESIA USING TRANS-THORACIC ECHOCARDIOGRAPHY |
Pre-Operative
3 minutes post induction of anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There is No Secondary Objective |
There is No Secondary Objective |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2021 |
| Date of Study Completion (India) |
26/04/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
26/04/2022 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Post induction hypotension is a known complication in patients undergoing general anaesthesia. It has been observed with both Thiopentone-Fentanyl and Propofol-Fentanyl as induction agents.
Hypotension in these scenarios may be due to decreased systemic vascular resistance or decreased systolic function of the heart.
While both Thiopentone and Propofol have ben studied extensively as standalone agents, their respective combinations with Fentanyl have not been studied thoroughly in patients undergoing non-cardiac surgeries under GA
We aim to study the effects of aforementioned combinations as induction agents for general anaesthesia on systolic function of the heart in a non-invasive manner with the help of trans-thoracic echocardiography in the operating room
|