| CTRI Number |
CTRI/2025/07/091175 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effects of vasodilating drugs in patients vitals while getting off from Heart Lung Machine |
|
Scientific Title of Study
|
A comparative study evaluating the effects of propofol and Nitroglycerine infusion on patients hemodynamic while weaning off from cardiopulmonary bypass posted for 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 |
Kanchan Gupta |
| Designation |
Junior Resident |
| Affiliation |
King Georges Medical University |
| Address |
Department Of Anaesthesiology,
King Georges Medical University, Lucknow
Shah Mina Road, Chowk, Lucknow-226003
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9528201667 |
| Fax |
|
| Email |
kanchangupta2707@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinita Singh |
| Designation |
Professor |
| Affiliation |
King Georges Medical University |
| Address |
Room No 2, Department of Anaesthesiology, King Georges Medical University, Lucknow
Shah Mina Road, Chowk, Lucknow-226003
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9415080782 |
| Fax |
|
| Email |
drvinitasingh70@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kanchan Gupta |
| Designation |
Junior Resident |
| Affiliation |
King Georges Medical University |
| Address |
Department Of Anaesthesiology,
King Georges Medical University, Lucknow
Shah Mina Road, Chowk, Lucknow-226003
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9528201667 |
| Fax |
|
| Email |
kanchangupta2707@gmail.com |
|
|
Source of Monetary or Material Support
|
| No monetary funding. Infrastructural Support by Department of Cardiothoracic-Vascular Surgery, KGMU, Lucknow |
|
|
Primary Sponsor
|
| Name |
Dr Kanchan Gupta |
| Address |
Department of Anaesthesiology and Critical care, KGMU, Lucknow |
| Type of Sponsor |
Other [SELF] |
|
|
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 Kanchan Gupta |
King Georges Medical University |
Shah Mina Road, Chowk, Lucknow
Lucknow
UTTAR PRADESH |
9528201667
kanchangupta2707@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, King Georges Medical University, U.P., |
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 |
Injection Nitroglycerine Infusion |
Injection Nitrogltcerine infusion is started while weaning off from cardio-pulmonary bypass. |
| Intervention |
Injection Propofol infusion. |
Propofol infusion is started while weaning off from Cardio-pulmonary bypass. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for Cardiac Surgeries. |
|
| ExclusionCriteria |
| Details |
1. Patients not willing to give informed consent
2. Extremes of age
3. Patients posted for CABG
4. Patients with severe systolic LV dysfunction.
5.patients posted for combined cardiac and major vascular surgeries.
6. Cardio-pulmonary Bypass time more than 90 minutes.
7. HbA1c more than 6.5
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effect of propofol infusion in achieving vasodilation and controlled hypotension perioperatively as compared to Nitroglycerine infusion. |
while weaning off from cardio-pulmonary bypass |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparison of total ionotropic requirement after separation of cardiopulmonary bypass among the two groups.
2. Comparison of hemodynamic fluctuations while shifting the patients from Operating room to ICU among the two groups. |
while weaning off from cardiopulmonary bypass and while shifting the patient to ICU |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
31/07/2025 |
| 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
|
This study is the randomized, double blinded study comparing the effects of propofol and Nitroglycerine infusion on patients hemodynamic while weaning off from cardiopulmonary bypass posted for cardiac surgery. The Primary objective is to measure the changes in hemodynamic such as vasodilation and controlled hypotension perioperatively while using these above mentioned drugs. The secondary objective is to compare the ionotropic requirement while using these drugs. |