| CTRI Number |
CTRI/2026/04/109020 [Registered on: 21/04/2026] Trial Registered Prospectively |
| Last Modified On: |
13/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to See Whether Dexmedetomidine Reduces Eye Pressure Changes in Patients Undergoing Beating-Heart Bypass Surgery” |
|
Scientific Title of Study
|
Effect of Dexmedetomidine on Intraocular Pressure changes during off-pump Coronary Artery Bypass Grafting (OPCAB): A Prospective, 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 |
Praveen NB |
| Designation |
Assistant professor |
| Affiliation |
Sri Jayadeva Institute of Cardiovascular Sciences & Research |
| Address |
1st floor, OT complex, Department of cardiac anaesthesia, Sri Jayadeva Institute of Cardiovascular Sciences & Research, Mysore. Mysore Mysore KARNATAKA 570016 India |
| Phone |
9619581468 |
| Fax |
|
| Email |
prvnnb@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Praveen NB |
| Designation |
Assistant professor |
| Affiliation |
Sri Jayadeva Institute of Cardiovascular Sciences & Research |
| Address |
1st floor, OT complex, Department of cardiac anaesthesia, Sri Jayadeva Institute of Cardiovascular Sciences & Research, Mysore. Mysore Mysore KARNATAKA 570016 India |
| Phone |
9619581468 |
| Fax |
|
| Email |
prvnnb@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Praveen NB |
| Designation |
Assistant professor |
| Affiliation |
Sri Jayadeva Institute of Cardiovascular Sciences & Research |
| Address |
1st floor, OT complex, Department of cardiac anaesthesia, Sri Jayadeva Institute of Cardiovascular Sciences & Research, Mysore. Mysore Mysore KARNATAKA 570016 India |
| Phone |
9619581468 |
| Fax |
|
| Email |
prvnnb@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sri jayadeva institute of cardiovascular sciences and research |
| Address |
Department of cardiac anaesthesia
Sri Jayadeva Institute of Cardiovascular Sciences & Research
KRS Road
Kumabara Koppalu
Mysore 570016 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Praveen NB |
Sri Jayadeva Institute of Cardiovascular Sciences and Research |
1st floor, OT complex, Department of cardiac anaesthesia Mysore KARNATAKA |
9619581468
prvnnb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Jayadeva institute of cardiovascular sciences and research |
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 |
| Intervention |
dexmedetomidine |
Loading dose: 1 mcg/kg over 10 minutes followed by Maintenance infusion: 0.5 mcg/kg/hour
Infusion continued till end of surgery
|
| Comparator Agent |
saline(placebo) |
Normal saline infusion in equivalent volume
Same duration as the dexmedetomidine group
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Triple vessel coronary artery disease
Scheduled for elective OPCAB surgery
|
|
| ExclusionCriteria |
|
|
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 |
| To compare intraocular pressure changes |
•T0 – Before induction
•T1 – 30 minutes after induction
•T2 – Prior to coronary anastomosis
•T3 – End of left anterior descending artery anastomosis
•T4 – End of left circumflex or posterior descending artery anastomosis (end of Trendelenburg position)
•T5 – End of surgery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare ocular perfusion pressure (OPP |
•T0 – Before induction
•T1 – 30 minutes after induction
•T2 – Prior to coronary anastomosis
•T3 – End of left anterior descending artery anastomosis
•T4 – End of left circumflex or posterior descending artery anastomosis (end of Trendelenburg position)
•T5 – End of surgery
|
| HR |
•T0 – Before induction
•T1 – 30 minutes after induction
•T2 – Prior to coronary anastomosis
•T3 – End of left anterior descending artery anastomosis
•T4 – End of left circumflex or posterior descending artery anastomosis (end of Trendelenburg position)
•T5 – End of surgery
|
| MAP |
•T0 – Before induction
•T1 – 30 minutes after induction
•T2 – Prior to coronary anastomosis
•T3 – End of left anterior descending artery anastomosis
•T4 – End of left circumflex or posterior descending artery anastomosis (end of Trendelenburg position)
•T5 – End of surgery
|
CVP
|
•T0 – Before induction
•T1 – 30 minutes after induction
•T2 – Prior to coronary anastomosis
•T3 – End of left anterior descending artery anastomosis
•T4 – End of left circumflex or posterior descending artery anastomosis (end of Trendelenburg position)
•T5 – End of surgery
|
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
04/05/2026 |
| 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="4" 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
|
Improved surgical and anesthetic techniques have made off pump coronary artery bypass surgery feasible. During this procedure grafting of the left circumflex and posterior descending arteries often requires a steep Trendelenburg position which increases intraocular pressure. This rise in pressure can reduce ocular perfusion and may lead to ischemic optic neuropathy and postoperative visual loss. Although rare these complications can be severe and permanent. The reported incidence of visual loss in cardiac and spine surgeries ranges from very low to around 0.2 percent and is multifactorial. Data specific to off pump surgery is limited but some studies suggest a measurable risk.
Studies comparing on pump and off pump cardiac surgery show that intraocular pressure decreases during cardiopulmonary bypass but increases during off pump procedures especially in the Trendelenburg position. Various anesthetic agents have been studied to control this increase with inconsistent results and there is limited evidence in off pump cardiac surgery.
Increased episcleral venous pressure is one of the mechanisms for raised intraocular pressure. Alpha 2 agonists reduce intraocular pressure by decreasing aqueous production and increasing outflow. Dexmedetomidine is a highly selective alpha 2 agonist that provides sedation and hemodynamic stability and has shown cardioprotective effects in off pump surgery. Based on these properties this study aims to evaluate whether dexmedetomidine can reduce the rise in intraocular pressure during off pump coronary artery bypass surgery. |