Status:
COMPLETED
Evaluation of Non-opioid Balanced General Anesthesia in Cardiac Surgery With Extracorporeal Circulation: a Randomized, Controlled, Multicenter Superiority Trial
Lead Sponsor:
Centre Hospitalier Universitaire Dijon
Conditions:
Opioid-free Anesthesia
Cardiac Surgery
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2024
Estimated Enrollment :
321 Patients enrolled
Trial Details
Trial ID
NCT04886453
Start Date
August 30 2021
End Date
March 21 2024
Last Update
May 17 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Chu Dijon Bourgogne
Dijon, France, 21000