Role of Opioid Free Anaesthesia in Elderly Patients Undergoing Elective Coronary Artery Bypass Graft Surgeries With Cardiopulmonary Bypass in Enhanced Recovery After Surgeries

The introduction of synthetic opioids in 1960 to general anesthesia together with sedative hypnotics and muscle relaxants allowed the appearance of the concept of multimodal balanced anesthesia. Although they help in achieving hemodynamic stability during anesthesia of open heart surgeries, their administration consequences are neither scarce nor benign to the patient. Perioperative opioids are associated with increased incidence of respiratory depression, prolonged mechanical ventilation, nausea and vomiting, prolonged sedation, Postoperative ileus (POI), urine retention, Postoperative cognitive dysfunction (POCD), immune depression and hyperalgesia (Beloeil et al., 2018).

Coronary artery bypass graft surgery with cardiopulmonary bypass (CPB) is particularly vulnerable to the above-mentioned complications. Indeed, some of the side effects of this surgery overlap with the adverse effects of opioids. Postoperative pulmonary complications are observed in up to 50% of patients (Fisscher et al., 2022) and POCD or delirium in 4-54% according to studies (Bhushan et al., 2021). Whereas major gastrointestinal complications are estimated to occur in around 3% of patients, essentially acute pancreatitis, postoperative ileus (Marsoner et al., 2019).

Opioid-free anesthesia (OFA) strategies have emerged to avoid intraoperative opioid use. It is based on the fact that a sympathetic reaction evidenced by hemodynamic changes in an anesthetised patient does not systematically reflect pain. In addition, a sleeping patient will not recall pain, while hormonal stress and sympathetic and inflammatory reactions can be controlled by therapeutic classes

Study Overview

• Status: Not yet recruiting
• Conditions: CABG; Ketamine; Dexmedetomidine; Opioid Free Anesthesia; Opioid Based Anesthesia
• Intervention / Treatment: Drug: Opioid free anesthesia; Drug: Opioid based Anesthesia

Detailed Description

Study Procedures: o Randomization will allocate patients into two groups: Opioid-free (F) and Opioid-based (O) anesthesia, with numbers drawn from sealed envelopes. o Group F will receive analgesia through ketamine and dexmedetomidine based on Ideal Body Weight (IBW). o Group O will receive fentanyl for analgesia, also based on IBW. o IBW is calculated using ARDSnet formulas (Brower et al., 2000). o For men, IBW is 50 + (0.91 × [height in cm - 152.4]). o For women, IBW is 45.5 + (0.91 × [height in cm - 152.4]). o Patients will be monitored with ECG, pulse oximeter, and blood pressure monitoring before receiving midazolam for sedation. o After catheter insertion, patients will be assigned to groups based on the analgesia provided. o The analgesia will be prepared in a pharmacy, coded for blinding the anaesthetist. Fentanyl will be administered as follows: 3 mg/kg (IBW) for induction and 5 mg/kg for infusion during surgery (Baerdemaeker et al., 2004). • Ketamine and dexmedetomidine will be combined in one syringe with specific dosages for induction and infusion (Mulier et al., 2018). o Both groups will receive general anesthesia induction with midazolam, group-specific analgesia, propofol, and rocuronium before intubation. o Anesthesia maintenance will include isoflurane, group-specific analgesia infusion, and rocuronium infusions (Basagan et al., 2010).Hemodynamic parameters will be recorded at various intervals before and after induction until the patient is transferred to ICU. A 5mg bolus from the analgesia syringe will be administered for persistent tachycardia or hypertension, with a maximum of three doses before switching to second-line treatments. Norepinephrine will be given for significant hypotension. Propranolol will be administered for persistent tachycardia. Nitroglycerin will be used for persistent hypertension. Atropine will be given for severe bradycardia. Bradycardia, tachycardia, hypotension, and hypertension are defined based on specific heart rate and blood pressure changes. Propofol infusion will commence while on bypass and stop after weaning. Analgesia infusion will cease after sternum closure. Inhalational anesthetics will be discontinued at the end of the surgery, and patients will be transferred intubated and ventilated to ICU. In ICU, patients will be extubated once they meet specific requirements. Each group will be monitored for extubation timing and incidence of POCD using CAM ICU score. Cortisol levels and neutrophil lymphocytic ratio will be measured postoperatively in ICU. Patients will be excluded from the study for specific complications or delays. Post-operative analgesia will be administered regularly with paracetamol and fentanyl infusion or other analgesia in the respective groups.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mahmoud Mohamed Abdelrhman mohamed, Assistant lecturer; Phone Number: 01024242615; Email: Mahmoudbdel@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age group: above 65 years old of both sex. Undergoing an elective coronary artery bypass graft surgeries with cardiopulmonary bypass.

Exclusion Criteria:

• Past or ongoing history of drug abuse.
• Psychiatric disease and cognitive disorders.
• Inability to perform the confusion assessment method for the intensive care unit (CAM-ICU) test.
• EF<40 %.
• 1st or 2nd degree Heart block.
• HR <50 bpm.
• Allergy from drugs used in this study.
• Use of a left ventricular assist device, IAB or ECMO pri

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Opioid free anesthesia group; Patients will receive dexmedetomidine and ketamine	Drug: Opioid free anesthesia; group (F) receive dexmedetomidine and ketamine
Active Comparator: Opioid based group; Patients will receive fentanyl	Drug: Opioid based Anesthesia; Opioid based group receive fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enhanced recovery time	From transfer the patient to icu till extubation	24 hours
Enhanced recovery defined as time of extubation	Time from extubation after transfer to icu	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
POCD	Post operative delerium by cam score which has 4 features ....to diagnose delerium patient must have 3 features	1 week
Post operative opioid consumption	Total morphine consumption	IN the first 24 hour after surgery ...total morphine consumption
Cortisol level	cortisol level	24 hours

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: January 14, 2026
• First Posted (Actual): January 22, 2026

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 14, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: FMASU MD239/2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No