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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-90
SponsorAin Shams University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 %.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Opioid free anesthesia

    Drug

    group (F) receive dexmedetomidine and ketamine

  • Opioid based Anesthesia

    Drug

    Opioid based group receive fentanyl

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Opioid free anesthesia groupActive comparator 1 intervention
Group B: Opioid based groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Enhanced recovery time

From transfer the patient to icu till extubation

Time frame
24 hours
2

Enhanced recovery defined as time of extubation

Time from extubation after transfer to icu

Time frame
24 hours

Secondary outcomes

1

POCD

Post operative delerium by cam score which has 4 features ....to diagnose delerium patient must have 3 features

Time frame
1 week
2

Post operative opioid consumption

Total morphine consumption

Time frame
IN the first 24 hour after surgery ...total morphine consumption
3

Cortisol level

cortisol level

Time frame
24 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: