Opioid Free anesthesia in cardiac surgery: The OFACAR randomized clinical trial.

Summary

In a multicenter blinded RCT of 320 elective cardiac surgery patients, opioid-free anesthesia reduced a 30-day composite of postoperative complications versus sufentanil-based anesthesia (RR 0.90; P=0.049), with fewer cardiovascular and digestive complications and no deaths in the OFA group. The fragility index was 1, indicating results are hypothesis-generating and require confirmation.

Key Findings

• Primary composite complications at 30 days were lower with OFA (75.4%) versus opioid anesthesia (84.5%); RR 0.90 (95% CI 0.80–0.99), P=0.049.
• Cardiovascular complications decreased (64.2% vs 75.2%; RR 0.86; 95% CI 0.74–0.99), with less postoperative myocardial damage (61.6% vs 72.1%).
• Digestive complications were markedly reduced (2.5% vs 11.2%; RR 0.22; 95% CI 0.08–0.65); deaths occurred in control (n=6) but not in OFA (P=0.014).
• Fragility index for the primary endpoint was 1, indicating result sensitivity to a single event change.

Clinical Implications

OFA protocols (ketamine, dexamethasone, lidocaine, magnesium) may be considered within ERAS pathways for cardiac surgery to reduce complications, with careful monitoring and pending validation in larger trials.

Limitations

• Fragility index of 1 for the primary outcome indicates high result sensitivity.
• Only two centers and moderate sample size may limit generalizability; regimen components may not isolate individual drug effects.

Future Directions

Conduct larger, multicenter pragmatic RCTs to confirm efficacy and safety, explore component analyses of OFA regimens, and evaluate patient-centered outcomes (delirium, quality of recovery).