Phase III clinical trial comparing the efficacy and safety of adamgammadex with sugammadex for reversal of rocuronium-induced neuromuscular block
Authors' conclusion
Adamgammadex was non-inferior to sugammadex with a possible lower incidence of adverse drug reactions compared with sugammadex.
Study context
- Population
- Subjects with rocuronium-induced NMBrandomised
- Participants
- 310 subjects
- Comparison
- Adamgammadex vs sugammadex for reversal of rocuronium-induced NMB
- Primary endpoint
- Proportion of patients with TOF ratio ≥0.9 within 5 min
- Follow-up
- 5 min
Methodological detailsmulticentre, double-blind, positive-controlled, non-inferiority, phase III
- Multicentre
- Double-blind
- Positive-controlled
- Non-inferiority
- Phase III
Primary result
TOF ratio ≥0.9 within 5 min
Point estimate
1.3%
95% CI −4.6%, +1.3%
By group
As reported in the abstract
Secondary outcomes
Median, min
| Outcome | Adamgammadex | Sugammadex | Difference (95% CI) | |
|---|---|---|---|---|
| Time from start of administration to recovery of TOF ratio to 0.9 (key secondary)Upper limit lower than non-inferiority margin of 5 min | 2.25 (IQR 1.75–2.75) | 1.75 (IQR 1.50–2.00) | 0.50 (0.25–0.50) | |
| −0.200.20.40.6Difference (linear scale) |
- Time from start of administration to recovery of train-of-four (TOF) ratio to 0.9 (key secondary): non-inferiority margin 5 min
Other secondary outcomes
- No inferior results observed in secondary outcomes
Safety
| Outcome | P value |
|---|---|
| Adverse drug reactions (anaphylactic reaction, recurarisation, decreased heart rate, laryngospasm)Lower incidence with adamgammadex | P = 0.047 |
Original publication
Phase III clinical trial comparing the efficacy and safety of adamgammadex with sugammadex for reversal of rocuronium-induced neuromuscular block. Br J Anaesth. Published 25 November 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →