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NCT Number: NCT04886453

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

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

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Key information

Conditions

Opioid-free Anesthesia Cardiac Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chu Dijon Bourgogne

Dijon, 21000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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)

Treatment and study plan

Balanced general anesthesia without morphine

Drug

Balanced general anesthesia without morphine

Standard general anesthesia balanced with morphine

Drug

Standard general anesthesia balanced with morphine

Data Collection

Other

Data collection

Assessment of pain

Other

visual analog scale

Recovery quality score

Other

QoR15 questionnaire

Primary outcomes

  1. Occurrence of at least one postoperative complication

    Time frame: 30 days post-surgery

    Post-operative complications:

    • postoperative neurological dysfunction
    • acute renal failure
    • acute respiratory failure
    • cardiovascular complications
    • death

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: OFACAR

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 14, 2021
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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