Evaluation of Non-opioid Balanced General Anesthesia in Cardiac Surgery With Extracorporeal Circulation: a Randomized, Controlled, Multicenter Superiority Trial

NCT ID: NCT04886453

Last Updated: 2024-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 321 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-30
• Study Completion Date: 2024-03-21

Brief Summary

Opioid-free anesthesia (OFA) is a general anesthesia based on the use of hypnotics and non-opioid analgesics (lidocaine, ketamine, dexamethasone, esmolol). This technique has been used for the past 10 years, during which randomized and non-randomized studies have demonstrated a number of positive effects on cardiac function:

• better analgesia and decreased postoperative morphine consumption,
• better respiratory function,
• better hemodynamic stability,
• better postoperative cognitive function.

The hypothesis of the present study is that the use of OFA during cardiac surgery is associated with:

• Improved intraoperative hemodynamic stability
• A decrease in the incidence of postoperative complications
• A reduction in intensive care and hospital length of stay

Conditions

Opioid-free Anesthesia; Cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

Group Type: EXPERIMENTAL

Balanced general anesthesia without morphine

Intervention Type: DRUG

Balanced general anesthesia without morphine

Data collection

Intervention Type: OTHER

Data collection

Assessment of pain

Intervention Type: OTHER

visual analog scale

Recovery quality score

Intervention Type: OTHER

QoR15 questionnaire

Controle

Group Type: ACTIVE_COMPARATOR

Standard general anesthesia balanced with morphine

Intervention Type: DRUG

Standard general anesthesia balanced with morphine

Data collection

Intervention Type: OTHER

Data collection

Assessment of pain

Intervention Type: OTHER

visual analog scale

Recovery quality score

Intervention Type: OTHER

QoR15 questionnaire

Interventions

Balanced general anesthesia without morphine

Balanced general anesthesia without morphine

Intervention Type: DRUG

Standard general anesthesia balanced with morphine

Standard general anesthesia balanced with morphine

Intervention Type: DRUG

Data collection

Data collection

Intervention Type: OTHER

Assessment of pain

visual analog scale

Intervention Type: OTHER

Recovery quality score

QoR15 questionnaire

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patient who has provided written and informed consent
• Adult patient
• Patient undergoing cardiac surgery which is:

1. Scheduled

2. With bypass surgery

3. Of the following types: aortic valve surgery, mitral valve surgery, tricuspid valve surgery, atrial myxoma, coronary artery bypass surgery, aortic surgery, combined surgery

Exclusion Criteria

• Person not affiliated to national health insurance
• Person under legal protection (curatorship, guardianship)
• Person under court order
• Pregnant or breastfeeding woman
• Adult unable to express consent
• Patient already included once in the study
• Patient requiring emergency surgery within 24 hours
• Patients with hypersensitivity to local anesthetics or opiates or to any of the excipients in the products used
• Patients on antidepressants, neuroleptics such as non-selective MAOIs (iproniazid), selective A MAOI (moclobemide), selective B MAOI (selegiline) gabapentin (Neurontin®)
• Patients with an unprotected atrioventricular conduction disorder
• Patients with a prolonged QTc (> 450 ms) on preoperative ECG
• Patient with severe liver failure (PT< 30%)
• Patient suffering from respiratory failure (Long-term oxygen therapy patient except OSA)
• Patient with uncontrolled epilepsy
• Patient with preoperative cognitive dysfunction (MMS <24)
• Patient with intracranial hypertension
• Patient with chronic kidney failure (dialysis, creatinine > 200 μmol L-1)
• Patient with porphyria
• Patients treated with linezolid (Zyvoxid®)
• Patients with severe arterial hypotension (systolic BP<90 mmHg)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Dijon Bourgogne

Dijon, , France

Countries

France

Other Identifiers

BOUHEMAD PHRCI 2019

Identifier Type: -

Identifier Source: org_study_id