| CTRI Number |
CTRI/2023/11/060015 [Registered on: 20/11/2023] Trial Registered Prospectively |
| Last Modified On: |
31/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effects of remote ischemic preconditioning in cardiac patients undergoing off pump coronary
artery bypass grafting procedure |
|
Scientific Title of Study
|
Effects of remote ischemic preconditioning in patients undergoing off pump coronary artery bypass grafting procedure-A Randomised controlled study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Iswarya S |
| Designation |
Postgraduate |
| Affiliation |
SRM Medical College Hospital and Research Institute |
| Address |
Room no 209, B Block , 2nd floor Department of Anaesthesiology
SRM Medical college hospital
Potheri Kattankulathur kancheepuram
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8778202245 |
| Fax |
|
| Email |
iswaryasankar21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gayatri B |
| Designation |
Head of Department of Anaesthesiology |
| Affiliation |
SRM Medical College Hospital and Research institute |
| Address |
Room no 209 , B Block, 2nd floor Department of Anaesthesiology
SRM medical college hospital
Potheri kattankulathur
Kancheepuram
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9500092905 |
| Fax |
|
| Email |
gayathrii.r@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayatri B |
| Designation |
Head of Department of Anaesthesiology |
| Affiliation |
SRM Medical College Hospital and Research institute |
| Address |
Room no 209 , B Block, 2nd floor Department of Anaesthesiology
SRM medical college hospital
Potheri kattankulathur
Kancheepuram
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9500092905 |
| Fax |
|
| Email |
gayathrii.r@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital and Research Institution |
|
|
Primary Sponsor
|
| Name |
SRM Medical College Hospital and Research Institute |
| Address |
Room no 209 , B Block ,2nd floor, Department of Anaesthesiology Potheri Kattankulathur 603203 Kancheepuram TAMIL NADU |
| 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 Iswarya S |
SRM Medical College Hospital |
Room no 209,B Block, 2nd floor
Department of Anaesthesiology
Potheri Kattankullathur
Kancheepuram
TAMIL NADU |
8778202245
iswaryasankar21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee-Students |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Remote ischemic preconditioning free group |
Standard BP cuff will be placed in right upper arm and left lower limb and left uninflated |
| Intervention |
Remote ischemic preconditioning receiving group |
Standard BP cuff will be placed in right upper arm and left lower limb and inflated simultaneously to 200 mmHg for a period of 5 minutes and deflated to 0 mmHg for 5 minutes.The cycle will be repeated for four times that total duration of remote ischemic preconditioning will be 20 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient undergoing primary , elective OFF pump coronary bypass grafting procedure for double/triple coronary artery disease.
2.ASA 3 and 4 |
|
| ExclusionCriteria |
| Details |
1.Patient in cardiogenic shock
2.Cardiac arrest in current hospital admission
3. Pregnancy
4. Disease related to preoperative renal insufficiency , peripheral vascular disease , inotropic support before induction of anesthesia |
|
|
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 |
| Remote ischemic preconditioning will be associated with reduced perioperative concentration of cardiac troponin I in patients undergoing off pump coronary artery bypass grafting procedure |
Cardiac troponin I will be assessed at 24 hr,48hr,72hr postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Incidence of intraoperative and postoperative arrhythmia in first 72 hours.
2.Acute Kidney injury
3.Major adverse cardiac events
4.Duration of mechanical ventilation
5.Length of ICU stay |
Patients will be monitored in ICU for 72 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="134"
Sample Size from India="134"
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)
|
25/11/2023 |
| 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 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
Modification(s)
|
After getting informed written consent , patients will be randomly allocated into two groups by computer generated random numbers. Group A - Patients receiving remote ischemic preconditioning Group B - Patients free of remote ischemic preconditioning The patients in both the group will be premedicated with tablet Alprazolom 0.25mg on the night before surgery On the day of surgery patients in both the groups will be shifted on to the table and baseline monitors ie., non invasive bloop pressure , pulse oximetry and electrocardiography will be attached and baseline values will be recorded. Peripheral line will be secured with 16G venflon. Arterial line will be secured in left radial artery.Central venous pressure line will be secured in right internal jugular vein.Blood pressure cuff will be tied in right upper limb and left lower limb.Arterial blood pressure , Central venous pressure , lead 2 and 5 of ECG and nasopharyngeal temperature will be recorded will be recorded continuously. Before induction of anaesthesia, patients will be premedicated with Midazolam 0.05mg/kg.After adequate preoxygenation with 100% oxygen for 6 minutes , patients will be induced with Fentanyl 3mcg/kg , Etomidate 0.2 mg/kg and muscle relaxant vecuronium 0.1mg/kg .Trachea will be intubated with cuffed endotracheal tube and put on mechanical ventilation in volume control mode maintained using oxygen and nitrous oxide.Volatile agents sevoflurane will be used till 40 - 60 % of bispectral index attained. Remote ischemic preconditioning and control protocol will be initiated.One standard blood pressure cuff will be placed on right upper limb and other cuff on left lower limb.Before sternotomy incision the cuff will be inflated simultaneously to 200mmhg for 5 minutes and the deflated to 0 mmhg for 5 minutes.The cycle will be repeated four times so that the total duration of remote ischemic preconditioning will be 20 minutes. For control group(Group B)the cuff will placed on right upper arm and left lower limb. After all the grafts have been placed , the surgeons ensures that there is no bleeding from the graft sites and that the bypass grafts are functioning properly.The heart then carefully will be repositioned and the pericardium and sternum will be closed with sutures. The patients will be shifted to cardiac ICU and closely monitored The primary end point cardiac troponin I levels will be assessed At 24hr,48hr,72hr after cardiac bypass grafting.Urea,serum creatinine will be assessed every 24 hrs The secondary end point including the component of primary end point will be assessed at 30 days.
|