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Reversal of profound rocuronium-induced blockade with sugammadex: a randomized comparison with neostigmine.
Anesthesiology. 2008 Nov; 109(5):816-24.A

Abstract

BACKGROUND

Traditionally, reversal of nondepolarizing neuromuscular blocking agents was achieved using acetylcholinesterase inhibitors, but these are unable to adequately reverse profound blockade. Sugammadex is a novel reversal agent, reversing the effects of rocuronium by encapsulation. This study assessed the efficacy and safety of sugammadex versus neostigmine for reversal of profound rocuronium-induced neuromuscular blockade.

METHODS

This phase III, randomized study enrolled surgical patients, aged 18 yr or older with American Society of Anesthesiologists physical status I-IV. Patients were randomized to receive sugammadex (4.0 mg/kg) or neostigmine (70 microg/kg) plus glycopyrrolate (14 microg/kg). Anesthetized patients received an intubating dose of rocuronium (0.6 mg/kg), with maintenance doses (0.15 mg/kg) as required. Neuromuscular monitoring was performed by acceleromyography. Sugammadex or neostigmine was administered at reappearance of 1-2 posttetanic counts (profound neuromuscular blockade). The primary efficacy parameter was the time from sugammadex or neostigmine-glycopyrrolate administration to return of the train-of-four ratio to 0.9.

RESULTS

In the intent-to-treat population (n = 37 in each group), geometric mean time to recovery to a train-of-four ratio of 0.9 with sugammadex was 2.9 min versus 50.4 min with neostigmine-glycopyrrolate (P < 0.0001) (median, 2.7 min vs. 49.0 min). Most sugammadex patients (97%) recovered to a train-of-four ratio of 0.9 within 5 min after administration. In contrast, most neostigmine patients (73%) recovered between 30 and 60 min after administration, with 23% requiring more than 60 min to recover to a train-of-four ratio of 0.9.

CONCLUSIONS

Recovery from profound rocuronium-induced neuromuscular blockade was significantly faster with sugammadex versus with neostigmine, suggesting that sugammadex has a unique ability to rapidly reverse profound rocuronium neuromuscular blockade.

Authors+Show Affiliations

Accurate Clinical Trials/Saddleback Memorial Medical Center, Laguna Hills, CA 92653, USA. kevinjones@accurateclinicaltrials.netNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

18946293

Citation

Jones, R Kevin, et al. "Reversal of Profound Rocuronium-induced Blockade With Sugammadex: a Randomized Comparison With Neostigmine." Anesthesiology, vol. 109, no. 5, 2008, pp. 816-24.
Jones RK, Caldwell JE, Brull SJ, et al. Reversal of profound rocuronium-induced blockade with sugammadex: a randomized comparison with neostigmine. Anesthesiology. 2008;109(5):816-24.
Jones, R. K., Caldwell, J. E., Brull, S. J., & Soto, R. G. (2008). Reversal of profound rocuronium-induced blockade with sugammadex: a randomized comparison with neostigmine. Anesthesiology, 109(5), 816-24. https://doi.org/10.1097/ALN.0b013e31818a3fee
Jones RK, et al. Reversal of Profound Rocuronium-induced Blockade With Sugammadex: a Randomized Comparison With Neostigmine. Anesthesiology. 2008;109(5):816-24. PubMed PMID: 18946293.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Reversal of profound rocuronium-induced blockade with sugammadex: a randomized comparison with neostigmine. AU - Jones,R Kevin, AU - Caldwell,James E, AU - Brull,Sorin J, AU - Soto,Roy G, PY - 2008/10/24/pubmed PY - 2008/11/19/medline PY - 2008/10/24/entrez SP - 816 EP - 24 JF - Anesthesiology JO - Anesthesiology VL - 109 IS - 5 N2 - BACKGROUND: Traditionally, reversal of nondepolarizing neuromuscular blocking agents was achieved using acetylcholinesterase inhibitors, but these are unable to adequately reverse profound blockade. Sugammadex is a novel reversal agent, reversing the effects of rocuronium by encapsulation. This study assessed the efficacy and safety of sugammadex versus neostigmine for reversal of profound rocuronium-induced neuromuscular blockade. METHODS: This phase III, randomized study enrolled surgical patients, aged 18 yr or older with American Society of Anesthesiologists physical status I-IV. Patients were randomized to receive sugammadex (4.0 mg/kg) or neostigmine (70 microg/kg) plus glycopyrrolate (14 microg/kg). Anesthetized patients received an intubating dose of rocuronium (0.6 mg/kg), with maintenance doses (0.15 mg/kg) as required. Neuromuscular monitoring was performed by acceleromyography. Sugammadex or neostigmine was administered at reappearance of 1-2 posttetanic counts (profound neuromuscular blockade). The primary efficacy parameter was the time from sugammadex or neostigmine-glycopyrrolate administration to return of the train-of-four ratio to 0.9. RESULTS: In the intent-to-treat population (n = 37 in each group), geometric mean time to recovery to a train-of-four ratio of 0.9 with sugammadex was 2.9 min versus 50.4 min with neostigmine-glycopyrrolate (P < 0.0001) (median, 2.7 min vs. 49.0 min). Most sugammadex patients (97%) recovered to a train-of-four ratio of 0.9 within 5 min after administration. In contrast, most neostigmine patients (73%) recovered between 30 and 60 min after administration, with 23% requiring more than 60 min to recover to a train-of-four ratio of 0.9. CONCLUSIONS: Recovery from profound rocuronium-induced neuromuscular blockade was significantly faster with sugammadex versus with neostigmine, suggesting that sugammadex has a unique ability to rapidly reverse profound rocuronium neuromuscular blockade. SN - 1528-1175 UR - https://www.unboundmedicine.com/medline/citation/18946293/Reversal_of_profound_rocuronium_induced_blockade_with_sugammadex:_a_randomized_comparison_with_neostigmine_ L2 - http://anesthesiology.pubs.asahq.org/article.aspx?doi=10.1097/ALN.0b013e31818a3fee DB - PRIME DP - Unbound Medicine ER -