| CTRI Number |
CTRI/2024/07/071385 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Enhanced recovery after Cardiac surgery. |
|
Scientific Title of Study
|
A prospective randomized controlled trial to study
the advantage of implementation of enhanced recovery after
surgery (ERAS) protocol in cardiac surgery. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mukkala Satwik |
| Designation |
Junior Resident |
| Affiliation |
Shri B M Patil Medical College and hospital |
| Address |
OT complex,
Department of Cardiothoracic and Vascular surgery,
Shri B M Patil Medical College and Hospital,
Blde deemed to be university.
Bijapur
KARNATAKA
586103
India |
| Phone |
8985911997 |
| Fax |
|
| Email |
mukkalasatwik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivanand Karigar |
| Designation |
Professor |
| Affiliation |
Shri B M Patil medical college and hospital |
| Address |
3rd floor Ot complex,
Department of Anaesthesiology,
Shri B M Patil Medical College and Hospital,
Blde deemed to be university,
solapur road,
Vijayapura.
Bijapur
KARNATAKA
586103
India |
| Phone |
9164319345 |
| Fax |
|
| Email |
shivanandkarigar82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivanand Karigar |
| Designation |
Professor |
| Affiliation |
Shri B M Patil medical college and hospital |
| Address |
3rd floor Ot complex,
Department of Anaesthesiology,
Shri B M Patil Medical College and Hospital,
Blde deemed to be university,
solapur road,
Vijayapura.
KARNATAKA
586103
India |
| Phone |
9164319345 |
| Fax |
|
| Email |
shivanandkarigar82@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri B M Patil medical college and hospital,
BLDE deemed to be university,
Solapur road,
Vijayapura, 586103,
Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Shri B M Patil medical college and hospital |
| Address |
Bangaramma Sajjan campus,
solapur road,
vijayapura 586103, Karnataka
India. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shivanand Karigar |
Shri B M Patil Medical College hospital and research centre, |
Bangaramma sajjan campus,
solapur road,
vijayapura 586103.
Bijapur
KARNATAKA |
9164319345
shivanandkarigar82@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BLDE(DU)/IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I708||Atherosclerosis of other arteries, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ERAS protocol. |
strict temperature control following cardiopulmonary bypass (36.5 C to 37.2 C), strict non-opioid pain management, inj. ketorolac 30mg intravenously every 12th hourly, extubation after 2 to 4 hours surgery, early enteral feeding 2 to 4 hours after extubation, early mobilization. |
| Comparator Agent |
Routine protocol |
standard anesthesia protocol, liberal temperature control, opioids for post operative pain management, extubation after 4 to 6 hours of surgery, enteral feeding after 4 hours of extubation, mobilization after 6 to 8 hours of extubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patient scheduled for planned elective cardiac surgery, coronary artery bypass graft and cardiopulmonary bypass graft, ASA grades II III IV |
|
| ExclusionCriteria |
| Details |
Patients with overt congestive heart failure and morbid obesity BMI greater than 35, history of stroke or endocarditis, preoperative ejection fraction less than 35% by echocardiogram, abnormal liver function tests. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The length of hospital stay and opioid consumption |
First 24 hours in Intensive therapy unit. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time of extubation, time to ambulate , post operative complications |
post operative period |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
05/08/2024 |
| 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="0"
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
|
A Prospective Randomized Controlled Trial to Study The Advantage of Implementation of Enhanced Recovery After Surgery (ERAS) Protocol in Cardiac surgery This is the study i am doing to decrease the opioid consumption and decrease the length of hospital stay in the cardiac surgery patients, post operative pain management, early enteral feeding and early mobilization of cardiac patients . mukkala satwik junior resident, department of anaesthesiology, shri B M Patil medical college and hospital, vijayapura , karnataka ,586103. |