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

Timeline

Start

2021-08-30

Primary completion

2024-03-21

Completion

2024-03-21

Outcome

Met primary endpoint

paper the primary outcome occurred in 120 patients (75.4%) in the OFA group compared with 136 patients (84.5%) in the control group (Risk Ratio [RR], 0.90; PMID 42190101 ↗

paper 95% confidence interval [CI], 0.80-0.99; P = 0.049 PMID 42190101 ↗

Publications

• Guinot PG, Besch G, Jonval L, Nguyen M, Grelet T, Bouhemad B; for OFACAR study group.. Opioid Free anesthesia in cardiac surgery: The OFACAR randomized clinical trial. Anesthesiology. 2026 May 22. doi: 10.1097/ALN.0000000000006164. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexamethasone	Small molecule	—	Intravenous
Subject	Ketamine	Small molecule	—	Intravenous
Subject	Lidocaine	Other / unclassified	—	Intravenous
Subject	Magnesium Sulfate	Other / unclassified	—	Intravenous
Comparator	Morphine	Other / unclassified	—	—

Indications

No indication recorded.