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CTRI Number  CTRI/2025/09/095276 [Registered on: 22/09/2025] Trial Registered Prospectively
Last Modified On: 22/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Studying the Use of Opioid-Free Anaesthesia in Heart Bypass Surgery Patients to Improve Recovery After Surgery 
Scientific Title of Study   Opioid free anaesthesia for coronary revascularization surgery and its effect on post-operative recovery- An observational prospective 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  Dr Geetha Muniraju 
Designation  Senior consultant, Cardiac anaesthesia 
Affiliation  Fortis Hospital Limited 
Address  Department of Anesthesia Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore
Department of Anesthesia Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore
Bangalore
KARNATAKA
560076
India 
Phone  8971099794  
Fax    
Email  drgeethachetan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Geetha Muniraju 
Designation  Senior consultant, Cardiac anaesthesia 
Affiliation  Fortis Hospital Limited 
Address  Department of Anesthesia Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore
Department of Anesthesia Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore

KARNATAKA
560076
India 
Phone  8971099794  
Fax    
Email  drgeethachetan@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Geetha Muniraju 
Designation  Senior consultant, Cardiac anaesthesia 
Affiliation  Fortis Hospital Limited 
Address  Department of Anesthesia Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore
Department of Anesthesia Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore

KARNATAKA
560076
India 
Phone  8971099794  
Fax    
Email  drgeethachetan@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Academic Investigator Initiated study 
Address  Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore 
Type of Sponsor  Private hospital/clinic 
 
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 
Dr Geetha Muniraju  Fortis Hospital   Department of Anesthesia Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore
Bangalore
KARNATAKA 
8971099794

drgeethachetan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
FORTIS HOSPITAL INSTITUTIONAL ETHICS COMMITTEE   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  Inj Dexmedetomidine, Inj Lidocaine, Inj Ketamine  Inj Dexmedetomidine 0.25 µg/kg i.v is administered for 10min while securing central line and arterial line. A 50 ml solution containing 50 µg Inj Dexmedetomidine, 50 mg Inj Ketamine, and 500mg Inj Lidocaine is prepared. 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Good Left Ventricle Function Greater than 45 percentage Ejection Fraction.
2.No History of stroke, Central Nervous System disorders, any psychiatric medications
3.Adult patients 18 to 75 years old.
4.Scheduled for an elective Coronary Artery Bypass Graft.
5.Patient consent to participate in the study.
 
 
ExclusionCriteria 
Details  1.Reduced Left Ventricle function less than 45 percentage Ejection Fraction.
2.Known history of opioid abuse.
3.Bradycardia less than 50 beats per minute. Heart blocks greater than 2nd degree.
4.Contraindication to one of the trial drugs (dexmedetomidine, lidocaine, Magnesium sulphate, ketamine, non-­ steroidal anti-­ inflammatory drugs
5.Body mass index greater than or equal to 35 kg per meter square.
6.Combined cardiac surgeries other than aortic valve replacement.
7.Cognitive disorders.
8.Patients refusal consent.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To explore the efficacy of Opioid free anaesthesia in coronary vascularisation surgeries by assessing the quality of anesthesia, postoperative pain levels and adverse effects.   At the end of study duration data will be collected study duration 12 months  
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess the Haemodynamic response to intubation and surgery including incidence of bradycardia in the patients.
2.To assess the efficacy of the nerve blocks in terms of postoperative pain scores.
3.To monitor the depth of anaesthesia with BIS monitor.
4.Time taken for extubation.
5.overall patient satisfaction score.
6.Any adverse events.
 
To explore the efficacy of Opioid free anaesthesia in coronary vascularisation surgeries by assessing the quality of anesthesia, postoperative pain levels and adverse effects.  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   06/10/2025 
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  

Coronary revascularization surgery, a common procedure for the treatment of coronary artery disease, is traditionally associated with significant postoperative pain and opioid consumption. However, the use of opioids in the perioperative period can lead to a range of adverse effects, including respiratory depression, sedation, and the development of chronic opioid use. (Schwenk et al., 2018) To address these concerns, researchers have explored the feasibility and efficacy of opioid-free anesthesia for coronary revascularization surgery and its impact on postoperative recovery.

One of the key potential benefits of opioid-free anesthesia is the reduction in opioid consumption during the perioperative period. Studies have shown that the use of alternative analgesic agents, such as ketamine, can effectively manage pain without the need for high doses of opioids. Ketamine, an N-methyl-D-aspartate receptor antagonist, has been found to have analgesic properties and can be used in combination with other non-opioid medications to provide effective pain control. (Schwenk et al., 2018) Furthermore, the use of opioid-free anesthesia may have a positive impact on postoperative recovery, as it can reduce the incidence of opioid-related side effects, such as respiratory depression, sedation, and the development of chronic opioid use. (Hah et al., 2021). In a case report, researchers described the successful use of oral ketamine to treat opioid-resistant postoperative pain, highlighting the potential of this approach to reduce opioid requirements and improve pain management (Friedman et al., 2001).

In summary, the transition to opioid-free anesthesia for coronary revascularization surgeries introduces significant benefits that warrant further exploration and implementation. This approach mitigates the risks associated with opioid use, such as addiction potential and adverse side effects, while still addressing the critical need for effective pain management. Additionally, the importance of a thorough preoperative evaluation ties closely into the decision-making processes around anesthesia options, emphasizing the need for tailored approaches in clinical settings (Adams et al.). Ultimately, embracing opioid-free techniques not only aligns with emerging standards

 
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