Clinical trial NCT04886453: Evaluation of Non-opioid Balanced General Anesthesia in Cardiac Surgery With Extracorporeal Circulation: a Randomized, Controlled, Multicenter Superiority Trial
Official title: Evaluation of Non-opioid Balanced General Anesthesia in Cardiac Surgery With Extracorporeal Circulation: a Randomized, Controlled, Multicenter Superiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Opioid-free Anesthesia
Cardiac Surgery
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2021-05-14
Enrollment: 321
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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)

Primary outcomes:
measure: Occurrence of at least one postoperative complication
timeFrame: 30 days post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourgogne
Study officials:
References: