| CTRI Number |
CTRI/2025/02/081063 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Dexmedetomidine on Reducing Arrhythmias After Long Cardiopulmonary Bypass |
|
Scientific Title of Study
|
Role of Dexmedetomidine in reduction of arrhythmias post long cardiopulmonary bypass exposure |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kamna Nagar |
| Designation |
Post Graduate Resident |
| Affiliation |
King Georges Medical University Lucknow |
| Address |
Department of Anaesthesiology Gandhi Memorial and Associated Hospital King Georges Medical University Shahmina Road Lucknow
Department of Anaesthesiology Gandhi Memorial and Associated Hospital King Georges Medical University Shahmina Road Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8929299051 |
| Fax |
|
| Email |
kamnanagar98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Dinesh Kaushal |
| Designation |
Professor |
| Affiliation |
King Georges Medical University Lucknow |
| Address |
Department of Anaesthesiology Gandhi Memorial and Associated Hospital King Georges Medical University
Shahmina Road Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9839089242 |
| Fax |
|
| Email |
dineshkaushal91@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Dinesh Kaushal |
| Designation |
Professor |
| Affiliation |
King Georges Medical University Lucknow |
| Address |
Department of Anaesthesiology Gandhi Memorial and Associated Hospital King Georges Medical University
Shahmina Road Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9839089242 |
| Fax |
|
| Email |
dineshkaushal91@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Operation Theater Room No 2 Department of Anaesthesiology Gandhi Memorial and Associated Hospital King Georges Medical University Shahmina Road Lucknow |
|
|
Primary Sponsor
|
| Name |
Dr Kamna Nagar |
| Address |
Room No 2 Operation Theater Department of Anaesthesiology Gandhi Memorial and Associated Hospital King Georges Medical University Shahmina Road Lucknow Uttar Pradesh |
| 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 KAMNA NAGAR |
King Georges Medical University |
Room No 2 Operation Theater Department of Anaesthesiology Gandhi Memorial and Associated Hospital King Georges Medical University Shahmina Road Chowk Lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH |
8929299051
kamnanagar98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I499||Cardiac arrhythmia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Dexmedetomidine administered at a dose of 1 µg/kg over 10 minutes during rewarming in cardiopulmonary bypass surgery. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients scheduled for elective valve replacement surgery
2. Adult patients scheduled for congenital cardiac surgery
3. Patients providing written informed consent
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in the incidence of arrhythmias post long cardiopulmonary bypass exposure.
This includes monitoring ECG changes, heart rate, and the occurrence of arrhythmias (such as premature ventricular contractions, atrial fibrillation, and ventricular tachycardia) before induction, during surgery, and in the postoperative ICU period. |
36 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Advantage in fast-tracking recovery , Evaluating whether dexmedetomidine facilitates earlier extubation & ICU discharge.
2. Reduction in the use of long acting anti-arrhythmic drug infusions – Specifically assessing the decreased need for amiodarone or other anti-arrhythmic medications postoperatively. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="176"
Sample Size from India="176"
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)
|
03/03/2025 |
| 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 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
|
This study is a placebo-controlled, case-control trial conducted at King George’s Medical University, Lucknow, to evaluate the role of dexmedetomidine in reducing arrhythmias post long cardiopulmonary bypass (CPB) exposure.
Study Design: - **Type:** Case-control study - **Setting:** Department of Anaesthesiology & CTVS, KGMU - **Duration:** One year - **Sample Size:** 176 patients (88 per group) - **Groups:** - **Group A (Intervention):** Dexmedetomidine (1 µg/kg over 10 minutes during CPB rewarming) - **Group B (Control):** Placebo (normal saline)
Objectives: - **Primary Outcome: Reduction in the incidence of arrhythmias post-CPB (e.g., premature ventricular contractions, atrial fibrillation, ventricular tachycardia). - **Secondary Outcomes: - Fast-tracking recovery(earlier extubation, shorter ICU stay) - Reduced need for anti-arrhythmic drugs(e.g., amiodarone)
Time Points for Outcome Assessment: - Primary Outcome:** - Pre-induction (baseline), intraoperative (during CPB rewarming), and postoperative (ICU stay). - Secondary Outcomes: - **Fast-tracking recovery: Time to extubation and ICU discharge. - **Need for anti-arrhythmic drugs: Postoperative ICU period until hospital discharge.
Methodology: - Patients undergoing elective valve replacement or congenital cardiac surgery will be enrolled. - Randomization and allocation concealment methods are not explicitly mentioned but likely involve computer-generated sequences and sealed envelopes. - Statistical analysis will be done using SPSS and MS Excel, with a **p-value < 0.05** considered significant.
This study aims to determine whether dexmedetomidine administration during CPB rewarming can effectively reduce perioperative arrhythmias, improve hemodynamic stability and facilitate faster postoperative recovery. |