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

NCT04886453 | Completed Phase 3

• 1 other identifier: BOUHEMAD PHRCI 2019
• Study Type: interventional
• Target: 321
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Occurrence of at least one postoperative complication

  Post-operative complications: * postoperative neurological dysfunction * acute renal failure * acute respiratory failure * cardiovascular complications * death

  30 days post-surgery

Study Arms (2)

Intervention

EXPERIMENTAL

Drug: Balanced general anesthesia without morphine; Other: Data collection; Other: Assessment of pain; Other: Recovery quality score

Controle

ACTIVE COMPARATOR

Drug: Standard general anesthesia balanced with morphine; Other: Data collection; Other: Assessment of pain; Other: Recovery quality score

Interventions

Balanced general anesthesia without morphine DRUG

Balanced general anesthesia without morphine

Intervention

Standard general anesthesia balanced with morphine DRUG

Standard general anesthesia balanced with morphine

Controle

Data collection OTHER

Data collection

Controle; Intervention

Assessment of pain OTHER

visual analog scale

Controle; Intervention

Recovery quality score OTHER

QoR15 questionnaire

Controle; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient who has provided written and informed consent
• Adult patient
• Patient undergoing cardiac surgery which is:
• Scheduled
• With bypass surgery
• Of the following types: aortic valve surgery, mitral valve surgery, tricuspid valve surgery, atrial myxoma, coronary artery bypass surgery, aortic surgery, combined surgery

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

MeSH Terms

Interventions

Morphine; Data Collection

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 14, 2021
• Study Start: August 30, 2021
• Primary Completion: March 21, 2024
• Study Completion: March 21, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

FR (1)