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Reversal of rocuronium-induced (1.2 mg/kg) profound neuromuscular block by sugammadex: a multicenter, dose-finding and safety study.
Anesthesiology. 2007 Aug; 107(2):239-44.A

Abstract

BACKGROUND

Reversal of rocuronium-induced neuromuscular blockade can be accomplished by chemical encapsulation of rocuronium by sugammadex, a modified gamma-cyclodextrin derivative. This study investigated the efficacy and safety of sugammadex in reversing rocuronium-induced profound neuromuscular blockade at 5 min in American Society of Anesthesiologists physical status I and II patients.

METHODS

Forty-five American Society of Anesthesiologists physical status I and II patients (aged 18-64 yr) scheduled to undergo surgical procedures (anticipated anesthesia duration >/= 90 min) were randomly assigned to a phase II, multicenter, assessor-blinded, placebo-controlled, parallel, dose-finding study. Anesthesia was induced and maintained with propofol and an opioid. Profound neuromuscular blockade was induced with 1.2 mg/kg rocuronium bromide. Sugammadex (2.0, 4.0, 8.0, 12.0, or 16.0 mg/kg) or placebo (0.9% saline) was then administered 5 min after the administration of rocuronium. Neuromuscular function was monitored by acceleromyography, using train-of-four nerve stimulation. Recovery time was the time from the start of administration of sugammadex or placebo, to recovery of the train-of-four ratio to 0.9. Safety assessments were performed on the day of the operation and during the postoperative and follow-up period.

RESULTS

A total of 43 patients received either sugammadex or placebo. Increasing doses of sugammadex reduced the mean recovery time from 122 min (spontaneous recovery) to less than 2 min in a dose-dependent manner. Signs of recurrence of blockade were not observed. No serious adverse events related to sugammadex were reported. Two adverse events possibly related to sugammadex were reported in two patients (diarrhea and light anesthesia); however, both patients recovered without sequelae.

CONCLUSIONS

Sugammadex rapidly and effectively reversed profound rocuronium-induced neuromuscular blockade in humans and was well tolerated.

Authors+Show Affiliations

Department of Anesthesiology, Radboud University Medical Center Nijmegen, The Netherlands. pm.mertes@chu-nancy.frNo 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

17667567

Citation

de Boer, Hans D., et al. "Reversal of Rocuronium-induced (1.2 Mg/kg) Profound Neuromuscular Block By Sugammadex: a Multicenter, Dose-finding and Safety Study." Anesthesiology, vol. 107, no. 2, 2007, pp. 239-44.
de Boer HD, Driessen JJ, Marcus MA, et al. Reversal of rocuronium-induced (1.2 mg/kg) profound neuromuscular block by sugammadex: a multicenter, dose-finding and safety study. Anesthesiology. 2007;107(2):239-44.
de Boer, H. D., Driessen, J. J., Marcus, M. A., Kerkkamp, H., Heeringa, M., & Klimek, M. (2007). Reversal of rocuronium-induced (1.2 mg/kg) profound neuromuscular block by sugammadex: a multicenter, dose-finding and safety study. Anesthesiology, 107(2), 239-44.
de Boer HD, et al. Reversal of Rocuronium-induced (1.2 Mg/kg) Profound Neuromuscular Block By Sugammadex: a Multicenter, Dose-finding and Safety Study. Anesthesiology. 2007;107(2):239-44. PubMed PMID: 17667567.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Reversal of rocuronium-induced (1.2 mg/kg) profound neuromuscular block by sugammadex: a multicenter, dose-finding and safety study. AU - de Boer,Hans D, AU - Driessen,Jacques J, AU - Marcus,Marco A E, AU - Kerkkamp,Hans, AU - Heeringa,Marten, AU - Klimek,Markus, PY - 2007/8/2/pubmed PY - 2007/9/22/medline PY - 2007/8/2/entrez SP - 239 EP - 44 JF - Anesthesiology JO - Anesthesiology VL - 107 IS - 2 N2 - BACKGROUND: Reversal of rocuronium-induced neuromuscular blockade can be accomplished by chemical encapsulation of rocuronium by sugammadex, a modified gamma-cyclodextrin derivative. This study investigated the efficacy and safety of sugammadex in reversing rocuronium-induced profound neuromuscular blockade at 5 min in American Society of Anesthesiologists physical status I and II patients. METHODS: Forty-five American Society of Anesthesiologists physical status I and II patients (aged 18-64 yr) scheduled to undergo surgical procedures (anticipated anesthesia duration >/= 90 min) were randomly assigned to a phase II, multicenter, assessor-blinded, placebo-controlled, parallel, dose-finding study. Anesthesia was induced and maintained with propofol and an opioid. Profound neuromuscular blockade was induced with 1.2 mg/kg rocuronium bromide. Sugammadex (2.0, 4.0, 8.0, 12.0, or 16.0 mg/kg) or placebo (0.9% saline) was then administered 5 min after the administration of rocuronium. Neuromuscular function was monitored by acceleromyography, using train-of-four nerve stimulation. Recovery time was the time from the start of administration of sugammadex or placebo, to recovery of the train-of-four ratio to 0.9. Safety assessments were performed on the day of the operation and during the postoperative and follow-up period. RESULTS: A total of 43 patients received either sugammadex or placebo. Increasing doses of sugammadex reduced the mean recovery time from 122 min (spontaneous recovery) to less than 2 min in a dose-dependent manner. Signs of recurrence of blockade were not observed. No serious adverse events related to sugammadex were reported. Two adverse events possibly related to sugammadex were reported in two patients (diarrhea and light anesthesia); however, both patients recovered without sequelae. CONCLUSIONS: Sugammadex rapidly and effectively reversed profound rocuronium-induced neuromuscular blockade in humans and was well tolerated. SN - 0003-3022 UR - https://www.unboundmedicine.com/medline/citation/17667567/Reversal_of_rocuronium_induced__1_2_mg/kg__profound_neuromuscular_block_by_sugammadex:_a_multicenter_dose_finding_and_safety_study_ L2 - http://anesthesiology.pubs.asahq.org/article.aspx?doi=10.1097/01.anes.0000270722.95764.37 DB - PRIME DP - Unbound Medicine ER -