| 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
|
|
|
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
|
|
|
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
|
|
|
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 |