Cardiac Surgery, Opioid-free Anesthesia
Conditions
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
Interventions
DRUGBalanced general anesthesia without morphine
Balanced general anesthesia without morphine
DRUGStandard general anesthesia balanced with morphine
Standard general anesthesia balanced with morphine
OTHERData collection
Data collection
OTHERAssessment of pain
visual analog scale
OTHERRecovery quality score
QoR15 questionnaire
Sponsors
Centre Hospitalier Universitaire Dijon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of at least one postoperative complication | 30 days post-surgery | Post-operative complications: * postoperative neurological dysfunction * acute renal failure * acute respiratory failure * cardiovascular complications * death |
Countries
France
Outcome results
None listed