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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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 
Details   
 
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.

 
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