Opioid-free Anesthesia in Cardiac Surgery: The OFACAR Randomized Clinical Trial

Area of Science:

• Anesthesiology
• Cardiovascular Surgery
• Critical Care Medicine

Background:

• Evidence for opioid-free anesthesia (OFA) in cardiac surgery is limited, despite potential benefits in reducing postoperative complications.
• A large randomized trial was needed to evaluate OFA's efficacy and safety in patients undergoing elective cardiac surgery.

Purpose of the Study:

• To determine if opioid-free anesthesia (OFA) is superior to traditional opioid anesthesia in reducing composite postoperative complications in patients undergoing cardiac surgery.
• To assess the impact of OFA on specific complications, including neurological, respiratory, cardiovascular, and renal events, as well as mortality.

Main Methods:

• A randomized, controlled, blinded, multicenter superiority trial was conducted with 320 adult patients undergoing elective cardiac surgery with cardiopulmonary bypass.
• Patients received either OFA (ketamine, dexamethasone, lidocaine, magnesium sulfate) or opioid anesthesia (sufentanil).
• The primary outcome was a composite of postoperative complications and/or death within 30 days.

Main Results:

• The primary composite outcome occurred in 75.4% of the OFA group versus 84.5% in the opioid group (RR, 0.90; P = 0.049).
• OFA significantly reduced cardiovascular complications (64.2% vs. 75.2%) and digestive complications (2.5% vs. 11.2%).
• No deaths occurred in the OFA group, compared to 6 in the opioid group (P=0.014).

Conclusions:

• Opioid-free anesthesia may reduce composite postoperative complications in patients undergoing cardiac surgery compared to opioid anesthesia.
• The fragility index suggests these findings are hypothesis-generating and require confirmation in larger studies.
• OFA demonstrated a potential safety benefit with a reduction in mortality and specific complication types.