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Sugammadex rapidly reverses moderate rocuronium- or vecuronium-induced neuromuscular block during sevoflurane anaesthesia: a dose-response relationship.
Br J Anaesth. 2010 Nov; 105(5):610-9.BJ

Abstract

BACKGROUND

Sugammadex shows a dose-response relationship for reversal of neuromuscular block (NMB) during propofol anaesthesia. Sevoflurane, unlike propofol, can prolong the effect of neuromuscular blocking agents (NMBAs), increasing recovery time. This open-label, randomized, dose-finding trial explored sugammadex dose-response relationships, safety, and pharmacokinetics when administered for reversal of moderate rocuronium- or vecuronium-induced NMB during sevoflurane maintenance anaesthesia.

METHODS

After anaesthesia induction with propofol, adult patients were randomized to receive single-dose rocuronium 0.9 mg kg⁻¹ or vecuronium 0.1 mg kg⁻¹, with maintenance doses as needed. Anaesthesia was maintained with sevoflurane. NMB was monitored using acceleromyography. After the last dose of NMBA, at reappearance of T(2), single-dose sugammadex 0.5, 1.0, 2.0, or 4.0 mg kg⁻¹ or placebo was administered. The primary efficacy variable was time from the start of sugammadex administration to recovery of T₄/T₁ ratio to 0.9. Safety assessments were performed throughout.

RESULTS

The per-protocol population comprised 93 patients (rocuronium, n=46; vecuronium, n=47). A statistically significant dose-response relationship was demonstrated for mean recovery times of T₄/T₁ ratio to 0.9 with increasing sugammadex dose with both NMBAs: rocuronium, 96.3 min (placebo) to 1.5 min (sugammadex 4.0 mg kg⁻¹); vecuronium, 79.0 min (placebo) to 3.0 min (sugammadex 4.0 mg kg⁻¹). Plasma sugammadex concentrations indicated linear pharmacokinetics, independent of NMBA administered. No study drug-related serious adverse events occurred. Evidence of reoccurrence of block was reported in seven patients [sugammadex 0.5 mg kg⁻¹ (suboptimal dose), n=6; 2.0 mg kg⁻¹, n=1].

CONCLUSIONS

During sevoflurane maintenance anaesthesia, sugammadex provides well-tolerated, effective, dose-dependent reversal of moderate rocuronium- and vecuronium-induced NMB.

Authors+Show Affiliations

Klinik für Anästhesiologie und Operative Intensivmedizin, Klinikum am Steinenberg, Reutlingen, Germany. puehringer_f@kreiskliniken-reutlingen.deNo 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

20876699

Citation

Pühringer, F K., et al. "Sugammadex Rapidly Reverses Moderate Rocuronium- or Vecuronium-induced Neuromuscular Block During Sevoflurane Anaesthesia: a Dose-response Relationship." British Journal of Anaesthesia, vol. 105, no. 5, 2010, pp. 610-9.
Pühringer FK, Gordon M, Demeyer I, et al. Sugammadex rapidly reverses moderate rocuronium- or vecuronium-induced neuromuscular block during sevoflurane anaesthesia: a dose-response relationship. Br J Anaesth. 2010;105(5):610-9.
Pühringer, F. K., Gordon, M., Demeyer, I., Sparr, H. J., Ingimarsson, J., Klarin, B., van Duijnhoven, W., & Heeringa, M. (2010). Sugammadex rapidly reverses moderate rocuronium- or vecuronium-induced neuromuscular block during sevoflurane anaesthesia: a dose-response relationship. British Journal of Anaesthesia, 105(5), 610-9. https://doi.org/10.1093/bja/aeq226
Pühringer FK, et al. Sugammadex Rapidly Reverses Moderate Rocuronium- or Vecuronium-induced Neuromuscular Block During Sevoflurane Anaesthesia: a Dose-response Relationship. Br J Anaesth. 2010;105(5):610-9. PubMed PMID: 20876699.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Sugammadex rapidly reverses moderate rocuronium- or vecuronium-induced neuromuscular block during sevoflurane anaesthesia: a dose-response relationship. AU - Pühringer,F K, AU - Gordon,M, AU - Demeyer,I, AU - Sparr,H J, AU - Ingimarsson,J, AU - Klarin,B, AU - van Duijnhoven,W, AU - Heeringa,M, Y1 - 2010/09/28/ PY - 2010/9/30/entrez PY - 2010/9/30/pubmed PY - 2010/11/11/medline SP - 610 EP - 9 JF - British journal of anaesthesia JO - Br J Anaesth VL - 105 IS - 5 N2 - BACKGROUND: Sugammadex shows a dose-response relationship for reversal of neuromuscular block (NMB) during propofol anaesthesia. Sevoflurane, unlike propofol, can prolong the effect of neuromuscular blocking agents (NMBAs), increasing recovery time. This open-label, randomized, dose-finding trial explored sugammadex dose-response relationships, safety, and pharmacokinetics when administered for reversal of moderate rocuronium- or vecuronium-induced NMB during sevoflurane maintenance anaesthesia. METHODS: After anaesthesia induction with propofol, adult patients were randomized to receive single-dose rocuronium 0.9 mg kg⁻¹ or vecuronium 0.1 mg kg⁻¹, with maintenance doses as needed. Anaesthesia was maintained with sevoflurane. NMB was monitored using acceleromyography. After the last dose of NMBA, at reappearance of T(2), single-dose sugammadex 0.5, 1.0, 2.0, or 4.0 mg kg⁻¹ or placebo was administered. The primary efficacy variable was time from the start of sugammadex administration to recovery of T₄/T₁ ratio to 0.9. Safety assessments were performed throughout. RESULTS: The per-protocol population comprised 93 patients (rocuronium, n=46; vecuronium, n=47). A statistically significant dose-response relationship was demonstrated for mean recovery times of T₄/T₁ ratio to 0.9 with increasing sugammadex dose with both NMBAs: rocuronium, 96.3 min (placebo) to 1.5 min (sugammadex 4.0 mg kg⁻¹); vecuronium, 79.0 min (placebo) to 3.0 min (sugammadex 4.0 mg kg⁻¹). Plasma sugammadex concentrations indicated linear pharmacokinetics, independent of NMBA administered. No study drug-related serious adverse events occurred. Evidence of reoccurrence of block was reported in seven patients [sugammadex 0.5 mg kg⁻¹ (suboptimal dose), n=6; 2.0 mg kg⁻¹, n=1]. CONCLUSIONS: During sevoflurane maintenance anaesthesia, sugammadex provides well-tolerated, effective, dose-dependent reversal of moderate rocuronium- and vecuronium-induced NMB. SN - 1471-6771 UR - https://www.unboundmedicine.com/medline/citation/20876699/Sugammadex_rapidly_reverses_moderate_rocuronium__or_vecuronium_induced_neuromuscular_block_during_sevoflurane_anaesthesia:_a_dose_response_relationship_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0007-0912(17)33439-6 DB - PRIME DP - Unbound Medicine ER -