Efficacy and safety of adamgammadex for reversing rocuronium-induced deep neuromuscular block: a multicentre, randomised, double-blind, positive-controlled phase III trial.

Summary

In a multicentre, double-blind phase III noninferiority RCT (n=321), adamgammadex 8 mg/kg rapidly reversed deep rocuronium-induced neuromuscular block with a 98.7% success rate to TOFR 0.9, noninferior to sugammadex (100%). Median time to TOFR 0.9 was 2.5 vs 2.2 minutes, and safety profiles were comparable.

Key Findings

• Noninferiority achieved for TOFR 0.9 recovery success: 98.7% (adamgammadex) vs 100% (sugammadex); difference -1.3% (95% CI -4.6 to 1.2).
• Median time to TOFR 0.9: 2.5 minutes (adamgammadex) vs 2.2 minutes (sugammadex); between-group difference 0.5 minutes (95% CI 0.3 to 0.7), within noninferiority margin.
• No significant differences in safety profile between groups.

Clinical Implications

Adamgammadex could expand options for reliable reversal of deep rocuronium block, aiding throughput and safety in the OR/PACU. Adoption will depend on availability, cost, and postmarketing safety data.

Limitations

• Details of dosing strata and subgroup analyses are limited in the abstract
• Long-term safety and rare adverse events require postmarketing surveillance

Future Directions

Head-to-head cost-effectiveness studies versus sugammadex; evaluation in special populations (renal impairment, pediatrics) and across varying depths of block.