| CTRI Number |
CTRI/2025/06/089623 [Registered on: 26/06/2025] Trial Registered Prospectively |
| Last Modified On: |
10/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the effects of intraoperative opioid sparing effects vs opioid free anaesthesia on post operative rescue analgesic consumption |
|
Scientific Title of Study
|
Comparing the Effect of Intraoperative Opioid Sparing Effect of Opioid-free Anaesthesia vs Opioid Anaesthesia on post operative Rescue Analgesic consumption in cardiac surgeries: A
Prospective Randomized 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 Kiran Muthu Rajah |
| Designation |
SENIOR RESIDENT |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
87, 5th street, Dr Kothari nagar, Ramapuram, Chennai
Department of Cardiac anaesthesia, Sri Ramachandra Institute of Higher Education and Research, no.1, Mount Poonamallee road, Porur
Chennai
TAMIL NADU
600089
India |
| Phone |
9600001484 |
| Fax |
|
| Email |
kiranmuthurajah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjith B Karthekeyan |
| Designation |
Professor and Head of Department |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Cardiac anaesthesia, Sri Ramachandra Institute of Higher Education and Research
Chennai
TAMIL NADU
600089
India |
| Phone |
9841136568 |
| Fax |
|
| Email |
ranjithkarthekeyan@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranjith B Karthekeyan |
| Designation |
Professor and Head of Department |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Cardiac anaesthesia, Sri Ramachandra Institute of Higher Education and Research
TAMIL NADU
600089
India |
| Phone |
9841136568 |
| Fax |
|
| Email |
ranjithkarthekeyan@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kiranmuthrajah |
| Address |
C-6,Sri Ramachandra Institute of Higher Education and Research,
Sri Ramachandra nagar, Porur, Chennai-600116 |
| 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 Kiran Muthu Rajah |
Sri Ramachandra Institute of Higher Education and Research |
6th floor, Udayar block, Mount Poonamallee road, Sriramachandra nagar, Porur
Chennai
TAMIL NADU |
9600001484
kiranmuthurajah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of Higher Education and Research Institutional Research ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I229||Subsequent ST elevation (STEMI) myocardial infarction of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Opioid sparing anaesthesia versus opioid using conventional anaesthesia in patients undergoing off pump coronary artery bypass grafting |
By monitoring overall opioid consumption and comparing the overall recovery of the patient postoperatively. Duration of intervention will be limited only during the interoperate period and monitoring will be starting from immediate post operative period. Time duration of monitoring - Post operative day 0 / 1 / 2 |
| Comparator Agent |
Opioid sparing group - Using Ketamine / Lignocaine / Dexmedetomedine infusions
Conventional opioid analgesia - Using opioid dependent analgesia
|
Overall opioid reduction can result in better patient recovery by decreasing hospital stay, opioid dependance and overall recovery of the patient. Thus by addition of ketamine as an alternative to opioid dependent analgesia improves overall outcome of the patient. By comparison of perioperative opioid consumption in both the groups the effect of opioid sparing analgesia can be proven as alternative by addition of ketamine as an alternative. Post operative day 0 / 1 / 2 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. 18 years of age or older
2.Scheduled for elective cardiac surgery with general anesthesia, invasive mechanical ventilation, complete median sternotomy |
|
| ExclusionCriteria |
| Details |
1. Patients were excluded in case of emergent or redo surgeries
2. Patients with history of COPD.
3. Patients with known pulmonary Hypertension
4. Patients with EF less than 40% in Echocardiography
5. Patients with significant history of smoking addiction
6. Body mass index more than 35 kg/ m2
7. Obstructive sleep apnea
8. Patient Refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total dosage of rescue analgesic usage - Post extubation in ICU |
Post operative time 0 minutes / 30 minutes / 1 hour / 2 hour / 4 hour / 8 hour / 10 hour / 12 hour / 14 hour / 16 hour / 18 hour / 20 hour / 22 hour / 24 hour
Post operative day 0 / 1 / 2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Time from discontinuation of inhalation anaesthetic to time of extubation
2.VAS score on POD 1 / 2 / 3
3.Hemodynamic changes
4.Duration of ICU stay |
30mins/1hour/2hour/4hour/6hour/8hour/10hour/12hour/14hour/16hour/18hour/20hour/22hour/24hour |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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)
|
10/07/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 prospective randomised study was conducted to compare the intraoperative opioid-free anaesthesia versus conventional opioid-based anaesthesia on postoperative rescue analgesic consumption in patients undergoing cardiac surgery. Patients scheduled for elective cardiac procedures were randomly assigned to receive either an opioid free anaesthesia regimen-utilising non opioid agents such as dexmedetomedine, ketamine, lignocaine and paracetamol or standard opioid basal protocol. The outcomes was measure as total postoperative rescue analgesic requirement within the first 24 hours after surgery and evaluation of pain scores, hemodynamic stability, incidence of opioid related side effects. The study aimed to determine whether OFA could effectively reduce postoperative analgesic needs while maintaining adequate pain control and hemodynamic safety in cardiac surgical patients. |