| CTRI Number |
CTRI/2024/07/071613 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
27/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A COMPARASON OF EFFECTS OF KETAMINE-DEXMEDETOMIDINE
VERSUS FENTANYL-PROPOFOL IN PATIENTS UNDERGOING CARDIAC
SURGERY FOR MYOCARDIAL PROTECTION |
|
Scientific Title of Study
|
A RANDOMISED COMPARATIVE STUDY FOR CARDIAC
PRECONDITIONING EFFECT OF KETAMINE-DEXMEDETOMIDINE
VERSUS FENTANYL-PROPOFOL IN PATIENTS UNDERGOING CARDIAC
SURGERY IN THE DEPARTMENT OF ANAESTHESIA. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anjum Saiyed |
| Designation |
Senior professor |
| Affiliation |
SMS Medical College |
| Address |
Department of Anaesthesiology, Second floor, Dhanvantri building, JLN marg, Jaipur.
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN
302001
India |
| Phone |
9214021930 |
| Fax |
|
| Email |
dranjumsaiyed@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjum Saiyed |
| Designation |
Senior professor |
| Affiliation |
SMS Medical College |
| Address |
Department of Anaesthesiology, Second floor, Dhanvantri building, JLN marg, Jaipur.
Jaipur
RAJASTHAN
RAJASTHAN
302001
India |
| Phone |
9214021930 |
| Fax |
|
| Email |
dranjumsaiyed@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jaskaran Singh Marjara |
| Designation |
Junior resident |
| Affiliation |
SMS Medical college |
| Address |
Department of Anaesthesiology, Second floor, Dhanvantri building, JLN marg, Jaipur.
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN
302001
India |
| Phone |
7347571313 |
| Fax |
|
| Email |
marjarajs1313@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Second floor, Dhanvantri OPD, JLN marg, Jaipur, Rajasthan, India - 302001 |
|
|
Primary Sponsor
|
| Name |
SMS Medical College and Hospital |
| Address |
Department of Anaesthesiology, Second floor, Dhanvantri OPD, JLN marg, Jaipur, Rajasthan, India - 302001 |
| Type of Sponsor |
Government 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 Jaskaran Singh Marjara |
SMS Medical college and hospital |
202, Cardiac Surgery OT, Second floor, Bangad building, JLN marg, Jaipur, Rajasthan, India - 302001
Jaipur
RAJASTHAN |
7347571313
marjarajs1313@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Ethics Comittee,SMS Medical college and attached hospitals, Jaipur |
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 |
| Comparator Agent |
Comparison of ketamine-dexmedetomidine and fentanyl-propofol for cardiac preconditioning |
Both groups will be compared for Trop-I levels, Mean CK-MB levels, Mean serum cortisol levels. |
| Intervention |
Group A- Ketamine-Dexmedetomidine |
This group involves infusion of Ketamine and Dexmedetomidine that will be administered intra operatively for cardiac preconditioning of cardiac bio markers I.e Troponin I, serum cortisol and CPK-MB. |
| Intervention |
Group B- Fentanyl-propofol |
This group involves infusion of Fentanyl and propofol that will be administered intra operatively for cardiac preconditioning of cardiac bio markers I.e Troponin I, serum cortisol and CPK-MB. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Informed written consent for the study
2. All patients will be American Society of Anaesthesiologists physical status II-III.
3. Aged between 18 and 70 years.
4. Weight between 40 and 70 kg.
5. BMI less than 30.
6. New York Heart Association classification of cardiac function II-III,
7. Ejection fraction greater than 40% |
|
| ExclusionCriteria |
| Details |
1. Patient should not part of any other study.
2. Non cooperative patient.
3. Patient with history of acute myocardial infarction.
4. Elevated levels of circulating cardiac troponin
5. History of endocrine, metabolic, neurological and psychotic disorder
6. History of previous unusual response to ketamine, dexmedotomidine, fentanyl,
propofol |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the Plasma cardiac troponin-I, CK-MB level, serum cortisol level in Ketamine-dexmedetomidine group and fentanyl-propofol group |
Blood samples will be drawn before induction, 4 hours after aortic cross clamping and 24 hours after aortic cross clamping. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIl |
NIL |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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 3 |
|
Date of First Enrollment (India)
|
07/08/2024 |
| 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="0"
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
|
Patient arrival in OT
Wt, fasting status, written informed consent and PAC will be checked; Monitoring of patient started using pulse oximeter and ECG.
Randomisation
IV line will be secured. IJV and invasive arterial line will be secured under local anaesthesia.
After preoxygenation with 100% oxygen, induction will be done with Inj. Midazolam 0.05mg/kg,Inj. Fentanyl 4 microgram/kg, Inj. Propofol 2mg/kg and Inj. Rocuronium0.9mg/kg OR Inj. Midazolam 0.05mg/kg, Inj. Dexmedetomidine 1 microgram/kg, Inj. ketamine 2mg/kg and Inj. Rocuronium0.9mg/kg
Blood samples for cardiac biomarkers will be collected at specified time intervals. |