Half dose sugammadex combined with neostigmine is non-inferior to full dose sugammadex for reversal of rocuronium-induced deep neuromuscular blockade: a cost-saving strategy

Marie T Aouad, Waseem S Alfahel, Roland N Kaddoum, Sahar M Siddik-Sayyid, Marie T Aouad, Waseem S Alfahel, Roland N Kaddoum, Sahar M Siddik-Sayyid

Abstract

Background: Sugammadex reverses the effect of rocuronium more rapidly and effectively than neostigmine, at all levels of neuromuscular blockade (NMB). However, its cost is prohibitive. The combination of half dose sugammadex with neostigmine would be non-inferior to full dose sugammadex for the reversal of deep NMB. This approach would reduce the cost of sugammadex while preserving its efficacy.

Methods: Patients were randomly allocated to receive sugammadex 4 mg/kg (Group S) or sugammadex 2 mg/kg with neostigmine 50 μg/kg and glycopyrrolate 10 μg/kg (Group NS) for reversal of rocuronium deep NMB. The primary outcome was the percentage of patients who recovered to 90% Train of Four (TOF) ratio within 5 min. The non-inferiority margin was set at 10%.

Results: Twenty eight patients were enrolled in each group. The number of patients who reached 90% TOF ratio within 5 min was 27 out of 28 (96%) in group S versus 25 out of 28 (89%) in group NS by intention-to-treat (difference: 7%, 95% CI of the difference: -9% to 24%). The number of patients who reached 90% TOF ratio within 5 min was 26 out of 26 (100%) in group S versus 23 out of 25 (92%) in group NS by per-protocol (difference: 8%, 95% CI of the difference: -6% to 25%).

Conclusions: Sugammadex 2 mg/kg with neostigmine 50 μg/kg was at worst 9% and 6% less effective than sugammadex 4 mg/kg by intention-to-treat and by per-protocol analysis respectively. Hence, the combination is non-inferior to the recommended dose of sugammadex.

Trial registration: Clinicaltrials.gov NCT 02375217 , registered on February 11, 2015.

Trial registration: ClinicalTrials.gov NCT02375217.

Keywords: Neuromuscular blockade; Rocuronium; Sugammadex.

Figures

Fig. 1
Fig. 1
Flow chart
Fig. 2
Fig. 2
Non-inferiority limit and 95% CI of the point estimate for the percent of patients who recovered TOF ratio of 0.9 within 5 min

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Source: PubMed

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