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Early reversal of profound rocuronium-induced neuromuscular blockade by sugammadex in a randomized multicenter study: efficacy, safety, and pharmacokinetics.
Anesthesiology. 2007 May; 106(5):935-43.A

Abstract

BACKGROUND

Sugammadex reverses the neuromuscular blocking effects of rocuronium by chemical encapsulation. The efficacy, safety, and pharmacokinetics of sugammadex for reversal of profound rocuronium-induced neuromuscular blockade were evaluated.

METHODS

Ninety-eight male adult patients were randomly assigned to receive sugammadex (1, 2, 4, 6, or 8 mg/kg) or placebo at 3, 5, or 15 min after 0.6 mg/kg rocuronium. Patients were anesthetized with propofol and fentanyl. The primary endpoint of the study was the time to achieve a recovery of train-of-four ratio to 0.9. Neuromuscular blockade was measured using acceleromyography. Concentrations of rocuronium and sugammadex were determined in venous blood and urine samples. A population pharmacokinetic model using NONMEM (GloboMax LLC, Hanover, MD) was applied.

RESULTS

The mean time to recovery of the train-of-four ratio to 0.9 after dosing at 3, 5, and 15 min decreased from 52.1, 51.7, and 35.6 min, respectively, after administration of placebo to 1.8, 1.5, and 1.4 min, respectively, after 8 mg/kg sugammadex. Sugammadex was safe and well tolerated. However, 20.4% of patients showed signs of inadequate anesthesia after its administration. The median cumulative excretion of rocuronium in the urine over 24 h was 26% in the placebo group and increased to 58-74% after 4-8 mg/kg sugammadex. The mean plasma clearances of sugammadex and rocuronium were 0.084 and 0.26 l/min, respectively.

CONCLUSIONS

In male subjects, sugammadex safely reversed profound neuromuscular blockade induced by 0.6 mg/kg rocuronium in a dose-dependent manner. Sugammadex enhanced the renal excretion of rocuronium, and its clearance is approximately one third that of rocuronium.

Authors+Show Affiliations

Department of Anesthesiology and Critical Care Medicine, Medical University Innsbruck, Innsbruck, Austria. harald.sparr@dornbirn.atNo 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

17457124

Citation

Sparr, Harald J., et al. "Early Reversal of Profound Rocuronium-induced Neuromuscular Blockade By Sugammadex in a Randomized Multicenter Study: Efficacy, Safety, and Pharmacokinetics." Anesthesiology, vol. 106, no. 5, 2007, pp. 935-43.
Sparr HJ, Vermeyen KM, Beaufort AM, et al. Early reversal of profound rocuronium-induced neuromuscular blockade by sugammadex in a randomized multicenter study: efficacy, safety, and pharmacokinetics. Anesthesiology. 2007;106(5):935-43.
Sparr, H. J., Vermeyen, K. M., Beaufort, A. M., Rietbergen, H., Proost, J. H., Saldien, V., Velik-Salchner, C., & Wierda, J. M. (2007). Early reversal of profound rocuronium-induced neuromuscular blockade by sugammadex in a randomized multicenter study: efficacy, safety, and pharmacokinetics. Anesthesiology, 106(5), 935-43.
Sparr HJ, et al. Early Reversal of Profound Rocuronium-induced Neuromuscular Blockade By Sugammadex in a Randomized Multicenter Study: Efficacy, Safety, and Pharmacokinetics. Anesthesiology. 2007;106(5):935-43. PubMed PMID: 17457124.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Early reversal of profound rocuronium-induced neuromuscular blockade by sugammadex in a randomized multicenter study: efficacy, safety, and pharmacokinetics. AU - Sparr,Harald J, AU - Vermeyen,Karel M, AU - Beaufort,Anton M, AU - Rietbergen,Henk, AU - Proost,Johannes H, AU - Saldien,Vera, AU - Velik-Salchner,Corinna, AU - Wierda,J Mark K H, PY - 2007/4/26/pubmed PY - 2007/5/30/medline PY - 2007/4/26/entrez SP - 935 EP - 43 JF - Anesthesiology JO - Anesthesiology VL - 106 IS - 5 N2 - BACKGROUND: Sugammadex reverses the neuromuscular blocking effects of rocuronium by chemical encapsulation. The efficacy, safety, and pharmacokinetics of sugammadex for reversal of profound rocuronium-induced neuromuscular blockade were evaluated. METHODS: Ninety-eight male adult patients were randomly assigned to receive sugammadex (1, 2, 4, 6, or 8 mg/kg) or placebo at 3, 5, or 15 min after 0.6 mg/kg rocuronium. Patients were anesthetized with propofol and fentanyl. The primary endpoint of the study was the time to achieve a recovery of train-of-four ratio to 0.9. Neuromuscular blockade was measured using acceleromyography. Concentrations of rocuronium and sugammadex were determined in venous blood and urine samples. A population pharmacokinetic model using NONMEM (GloboMax LLC, Hanover, MD) was applied. RESULTS: The mean time to recovery of the train-of-four ratio to 0.9 after dosing at 3, 5, and 15 min decreased from 52.1, 51.7, and 35.6 min, respectively, after administration of placebo to 1.8, 1.5, and 1.4 min, respectively, after 8 mg/kg sugammadex. Sugammadex was safe and well tolerated. However, 20.4% of patients showed signs of inadequate anesthesia after its administration. The median cumulative excretion of rocuronium in the urine over 24 h was 26% in the placebo group and increased to 58-74% after 4-8 mg/kg sugammadex. The mean plasma clearances of sugammadex and rocuronium were 0.084 and 0.26 l/min, respectively. CONCLUSIONS: In male subjects, sugammadex safely reversed profound neuromuscular blockade induced by 0.6 mg/kg rocuronium in a dose-dependent manner. Sugammadex enhanced the renal excretion of rocuronium, and its clearance is approximately one third that of rocuronium. SN - 0003-3022 UR - https://www.unboundmedicine.com/medline/citation/17457124/Early_reversal_of_profound_rocuronium_induced_neuromuscular_blockade_by_sugammadex_in_a_randomized_multicenter_study:_efficacy_safety_and_pharmacokinetics_ L2 - http://anesthesiology.pubs.asahq.org/article.aspx?doi=10.1097/01.anes.0000265152.78943.74 DB - PRIME DP - Unbound Medicine ER -