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Reversal of profound, high-dose rocuronium-induced neuromuscular blockade by sugammadex at two different time points: an international, multicenter, randomized, dose-finding, safety assessor-blinded, phase II trial.
Anesthesiology. 2008 Aug; 109(2):188-97.A

Abstract

BACKGROUND

Sugammadex (Org 25969), a novel, selective relaxant binding agent, was specifically designed to rapidly reverse rocuronium-induced neuromuscular blockade. The efficacy and safety of sugammadex for the reversal of profound, high-dose rocuronium-induced neuromuscular blockade was evaluated.

METHODS

A total of 176 adult patients were randomly assigned to receive sugammadex (2, 4, 8, 12, or 16 mg/kg) or placebo at 3 or 15 min after high-dose rocuronium (1.0 or 1.2 mg/kg) during propofol anesthesia. The primary endpoint was time to recovery of the train-of-four ratio to 0.9. Neuromuscular monitoring was performed using acceleromyography.

RESULTS

Sugammadex administered 3 or 15 min after injection of 1 mg/kg rocuronium decreased the median recovery time of the train-of-four ratio to 0.9 in a dose-dependent manner from 111.1 min and 91.0 min (placebo) to 1.6 min and 0.9 min (16 mg/kg sugammadex), respectively. After 1.2 mg/kg rocuronium, sugammadex decreased time to recovery of train-of-four from 124.3 min (3-min group) and 94.2 min (15-min group) to 1.3 min and 1.9 min with 16 mg/kg sugammadex, respectively. There was no clinical evidence of reoccurrence of neuromuscular blockade or residual neuromuscular blockade. Exploratory analysis revealed that prolongation of the corrected QT interval considered as possibly related to sugammadex occurred in one patient. Another two patients developed markedly abnormal arterial blood pressure after sugammadex that lasted approximately 15 min.

CONCLUSION

Sugammadex provides a rapid and dose-dependent reversal of profound neuromuscular blockade induced by high-dose rocuronium (1.0 or 1.2 mg/kg) in adult surgical patients.

Authors+Show Affiliations

Department for Anesthesiology and Intensive Care Medicine, Klinikum am Steinenberg, Reutlingen, Germany.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18648227

Citation

Pühringer, Friedrich K., et al. "Reversal of Profound, High-dose Rocuronium-induced Neuromuscular Blockade By Sugammadex at Two Different Time Points: an International, Multicenter, Randomized, Dose-finding, Safety Assessor-blinded, Phase II Trial." Anesthesiology, vol. 109, no. 2, 2008, pp. 188-97.
Pühringer FK, Rex C, Sielenkämper AW, et al. Reversal of profound, high-dose rocuronium-induced neuromuscular blockade by sugammadex at two different time points: an international, multicenter, randomized, dose-finding, safety assessor-blinded, phase II trial. Anesthesiology. 2008;109(2):188-97.
Pühringer, F. K., Rex, C., Sielenkämper, A. W., Claudius, C., Larsen, P. B., Prins, M. E., Eikermann, M., & Khuenl-Brady, K. S. (2008). Reversal of profound, high-dose rocuronium-induced neuromuscular blockade by sugammadex at two different time points: an international, multicenter, randomized, dose-finding, safety assessor-blinded, phase II trial. Anesthesiology, 109(2), 188-97. https://doi.org/10.1097/ALN.0b013e31817f5bc7
Pühringer FK, et al. Reversal of Profound, High-dose Rocuronium-induced Neuromuscular Blockade By Sugammadex at Two Different Time Points: an International, Multicenter, Randomized, Dose-finding, Safety Assessor-blinded, Phase II Trial. Anesthesiology. 2008;109(2):188-97. PubMed PMID: 18648227.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Reversal of profound, high-dose rocuronium-induced neuromuscular blockade by sugammadex at two different time points: an international, multicenter, randomized, dose-finding, safety assessor-blinded, phase II trial. AU - Pühringer,Friedrich K, AU - Rex,Christopher, AU - Sielenkämper,Andreas W, AU - Claudius,Casper, AU - Larsen,Per Bo, AU - Prins,Martine E, AU - Eikermann,Matthias, AU - Khuenl-Brady,Karin S, PY - 2008/7/24/pubmed PY - 2008/8/8/medline PY - 2008/7/24/entrez SP - 188 EP - 97 JF - Anesthesiology JO - Anesthesiology VL - 109 IS - 2 N2 - BACKGROUND: Sugammadex (Org 25969), a novel, selective relaxant binding agent, was specifically designed to rapidly reverse rocuronium-induced neuromuscular blockade. The efficacy and safety of sugammadex for the reversal of profound, high-dose rocuronium-induced neuromuscular blockade was evaluated. METHODS: A total of 176 adult patients were randomly assigned to receive sugammadex (2, 4, 8, 12, or 16 mg/kg) or placebo at 3 or 15 min after high-dose rocuronium (1.0 or 1.2 mg/kg) during propofol anesthesia. The primary endpoint was time to recovery of the train-of-four ratio to 0.9. Neuromuscular monitoring was performed using acceleromyography. RESULTS: Sugammadex administered 3 or 15 min after injection of 1 mg/kg rocuronium decreased the median recovery time of the train-of-four ratio to 0.9 in a dose-dependent manner from 111.1 min and 91.0 min (placebo) to 1.6 min and 0.9 min (16 mg/kg sugammadex), respectively. After 1.2 mg/kg rocuronium, sugammadex decreased time to recovery of train-of-four from 124.3 min (3-min group) and 94.2 min (15-min group) to 1.3 min and 1.9 min with 16 mg/kg sugammadex, respectively. There was no clinical evidence of reoccurrence of neuromuscular blockade or residual neuromuscular blockade. Exploratory analysis revealed that prolongation of the corrected QT interval considered as possibly related to sugammadex occurred in one patient. Another two patients developed markedly abnormal arterial blood pressure after sugammadex that lasted approximately 15 min. CONCLUSION: Sugammadex provides a rapid and dose-dependent reversal of profound neuromuscular blockade induced by high-dose rocuronium (1.0 or 1.2 mg/kg) in adult surgical patients. SN - 1528-1175 UR - https://www.unboundmedicine.com/medline/citation/18648227/Reversal_of_profound_high_dose_rocuronium_induced_neuromuscular_blockade_by_sugammadex_at_two_different_time_points:_an_international_multicenter_randomized_dose_finding_safety_assessor_blinded_phase_II_trial_ L2 - http://anesthesiology.pubs.asahq.org/article.aspx?doi=10.1097/ALN.0b013e31817f5bc7 DB - PRIME DP - Unbound Medicine ER -