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Reversal of Deep Pipecuronium-Induced Neuromuscular Block With Moderate Versus Standard Dose of Sugammadex

A Randomized, Double-Blind, Noninferiority Trial

Tassonyi, Edömér, MD, PhD, DSc*; Asztalos, László, MD*; Szabó-Maák, Zoltán, MD*; Nemes, Réka, MD*; Pongrácz, Adrienn, MD, PhD*; Lengyel, Szabolcs, PhD, DSc; Fülesdi, Béla, MD, PhD, DSc*

doi: 10.1213/ANE.0000000000003719
Anesthetic Clinical Pharmacology: Original Clinical Research Report

BACKGROUND: Certain surgical interventions may require a deep neuromuscular block (NMB). Reversal of such a block before tracheal extubation is challenging. Because anticholinesterases are ineffective in deep block, sugammadex 4 mg/kg has been recommended for the reversal of rocuronium- or vecuronium-induced deep NMB. However, this recommendation requires opening 2 vials of 200 mg sugammadex, which results in an increase in drug costs. Therefore, we sought a less expensive solution for the induction and reversal of deep NMB. Although the optimal dose of sugammadex for antagonism of deep block from pipecuronium has not been established, data pertaining to moderate block are available. Accordingly, we hypothesized that sugammadex 2 mg/kg would be a proper dose to reverse deep pipecuronium block, enabling us to avoid cost increases. In the present study, we compared sugammadex 2 mg/kg with the standard dose of 4 mg/kg for reversal of deep block from pipecuronium.

METHODS: This single-center, randomized, double-blind, 2 parallel-arms, noninferiority study comprised 50 patients undergoing general anesthesia with propofol, sevoflurane, fentanyl, and pipecuronium. Neuromuscular monitoring was performed with acceleromyography (TOF-Watch SX). Noninferiority margin was specified beforehand as an increase in reversal time of no >10% (corresponding to 1 minute for the primary outcome). When the block spontaneously recovered to posttetanic count 1, the patients randomly received sugammadex 2 or 4 mg/kg, and the time from the injection to the train-of-four (TOF) ratio of 1.0 was measured. Primary outcome was the time to achieve the normalized TOF ratio of 0.9 in a particular patient. Residual or recurrent postoperative NMB was additional end point.

RESULTS: Each patient recovered to the normalized TOF ratio of 0.9. In the 2 mg/kg group, reversal time was 1.73 ± 1.03 minutes (95% confidence interval [CI], 1.33–2.13; n = 25), and in the 4 mg/kg group, reversal time was 1.42 ± 0.63 minutes (mean ± standard deviation) (95% CI, 1.17–1.67; n = 25). The mean difference in reversal times between the 2 groups was 0.31 minutes (95% CI, −0.18 to 0.8), and the upper limit of CI was below the noninferiority margin of 1 minute. Postoperative block did not occur.

CONCLUSIONS: The effect of sugammadex 2 mg/kg was noninferior to that of 4 mg/kg in reversing posttetanic count-1 degree pipecuronium block. Sugammadex reversal of deep pipecuronium block appears to be effective.

From the *Department of Anesthesiology and Intensive Care, Faculty of Medicine, University of Debrecen, Debrecen, Hungary

Department of Tisza Research, Danube Research Institute, Centre for Ecological Research, Hungarian Academy of Sciences, Debrecen, Hungary.

Published ahead of print 12 July 2018.

Accepted for publication July 12, 2018.

Funding: Supported by the Hungarian Brain Research Program Grant 510 No. KTIA 13 NAP A II/5 and by departmental sources.

The authors declare no conflicts of interest.

Trial registration: The study is classified under the European Union Drug Regulaing Authorities Clinical Trials (EUDRACT) number 2015-002019-13 (URL:https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002019-13).

Reprints will not be available from the authors.

Address correspondence to Béla Fülesdi, MD, PhD, DSc, Department of Anesthesiology and Intensive Care, University of Debrecen, Nagyerdei krt. 98, H-4032 Debrecen, Hungary. Address e-mail to fulesdi@med.unideb.hu.

© 2018 International Anesthesia Research Society
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