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

NCT07360327 | Not Yet Recruiting

• 1 other identifier: FMASU MD239/2025
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

CABG; Dexmedetomidine; Ketamine; Opioid Free Anesthesia; Opioid Based Anesthesia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• POCD

  1 week

• Post operative opioid consumption

  IN the first 24 hour after surgery ...total morphine consumption

• Cortisol level

  24 hours

Study Arms (2)

Opioid free anesthesia group

ACTIVE COMPARATOR

Patients will receive dexmedetomidine and ketamine

Drug: Opioid free anesthesia

Opioid based group

ACTIVE COMPARATOR

Patients will receive fentanyl

Drug: Opioid based Anesthesia

Interventions

Opioid free anesthesia DRUG

group (F) receive dexmedetomidine and ketamine

Opioid free anesthesia group

Opioid based Anesthesia DRUG

Opioid based group receive fentanyl

Opioid based group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 %.
• st 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

Sponsors & Collaborators

• Ain Shams University: lead

Central Study Contacts

Mahmoud Mohamed Abdelrhman mohamed, Assistant lecturer

CONTACT

01024242615; Mahmoudbdel@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: January 22, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2025-10