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

Cardiac Surgery Clinical Trial

— OFACAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04886453
• Other study ID #: BOUHEMAD PHRCI 2019
• Status: Completed
• Phase: Phase 3
• Start date: August 30, 2021
• Est. completion date: March 21, 2024

Study information

• Verified date: May 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: March 21, 2024
• Est. primary completion date: March 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Drug:
• Balanced general anesthesia without morphine
Balanced general anesthesia without morphine
• Standard general anesthesia balanced with morphine
Standard general anesthesia balanced with morphine

Other:
• Data collection
Data collection
• Assessment of pain
visual analog scale
• Recovery quality score
QoR15 questionnaire

Locations

Country	Name	City	State
France	Chu Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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