| CTRI Number |
CTRI/2024/08/072225 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of tablet melatonin on heart enzymes in coronary artery bypass graft surgery |
|
Scientific Title of Study
|
A prospective randomized double blind study to assess the cardioprotective role of melatonin in patients undergoing coronary artery bypass graft 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 |
Anushka gautam |
| Designation |
Junior resident 2 |
| Affiliation |
Jawaharlal Nehru medical college Aligarh Muslim university |
| Address |
Junior resident at Jawahar Lal Nehru medical college in department of anesthesiology and critical care
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7905469112 |
| Fax |
|
| Email |
anushkamln97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nadeem Raza |
| Designation |
Assistant professor |
| Affiliation |
Jawahar Lal Nehru medical college Aligarh Muslim university |
| Address |
Department of anesthesiology and critical care at Jawahar Lal Nehru medical college,Aligarh Muslim university
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7417795018 |
| Fax |
|
| Email |
nadeemraza03@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nadeem Raza |
| Designation |
Assistant professor |
| Affiliation |
Jawahar Lal Nehru medical college Aligarh Muslim university |
| Address |
Depatment of anesthesiology and critical care at Jawahar Lal Nehru medical college ,Aligarh Muslim university
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7417795018 |
| Fax |
|
| Email |
nadeemraza03@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru medical jawahar nehru medical college Aligarh Muslim university , Aligarh, uttar pradesh,India.pincode 202002 |
|
|
Primary Sponsor
|
| Name |
Anushka gautam |
| Address |
Junior resident at department of anesthesiology and critical care JNMC ,AMU,ALIGARH, UP ,INDIA. |
| Type of Sponsor |
Other [Anushka gautam ] |
|
|
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 Nadeem raza |
Jawahar Lal Nehru medical college Aligrh Muslim university |
Department of anesthesiology and critical care,JNMC,AMU,ALIGAH,UP ,INDIA
Aligarh
UTTAR PRADESH |
7417795018
nadeemraza03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Jawahar Nehru medical college And hospital Aligarh Muslim university civil line Koil Aligarh uttar pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I257||Atherosclerosis of coronary arterybypass graft(s) and coronary artery of transplanted heart with angina pectoris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Assess the cardioprotective role of placebo in patients undergoing coronary artery bypass graft surgery |
Another group receive tablet placebo one time orally for two days before going to bed prior to surgery after that take one 1 sample before surgery and 3 continuous days collect sample after surgery .total 6 days intervention and monitoing.ckmb, tropi,hsCRP monitored .all samples taken for total 4 days.
Dose -10mg
Frequency-once daily at bed time for 2 days before surgery
Route of administration-oral Total duration-6 days |
| Intervention |
Assess the cardioprotective role of tablet melatonin in Patients undergoing coronary artery bypass graft surgery. |
One group receive tablet melatonin 10 mg one time orally for two days before going to bed prior to surgery after that take 1 sample before surgery and 3 continuous days collect sample after surgery .total 6 days intervention and monitoing.ckmb, tropi,hsCRP monitored .all samples taken for total 4 days.
Dose -10mg
Frequency-once daily for two days at bed time before surgery
Route of administration-oral
Total duration-6 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient undergoing elective coronary artery bypass graft surgery
BMI 18-40 kg/m2
ASA grade 1-3 |
|
| ExclusionCriteria |
| Details |
Patient refusal
Emergency coronary artery bypass graft surgery
Re-exploration coronary artery bypass graft surgery
Concomitant valve surgery
Associated severe lung disease or liver disease
Ejection fraction less than 30%
Patients with pace maker
Patients on antidepressants and mood stablizers |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of effect of preoperative oral melatonin on postoperative levels of cardiac biomarkers Trop-I, CK-MB ,highly sensitive CRP |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the effect of postoperative melatonin on :
1.preoperative anxiety
2.postoperative delirium
3.postoperative pain
4.cumulative opioid consumption. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/08/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="3" |
|
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
|
Coronary artery disease is one of the most common human disease .Angioplasties and coronary artery bypass grafts are two methods for treating coronary artery diseases. Injuries from ischemia - reperfusion following heart surgery are one of the most serious issues causing serious complications. Recently melatonin has emerged as potent , direct,free radical scavenger and indirect antioxidant.Therefore present study aims at assessing the effect of preoperative oral melatonin administration on preoperative anxiety ,Postoperative changes in levels of cardiac biomarkers CKMB,TROP-I, hs-CRP ,Postoperative pain and delirium. |