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Reversal of rocuronium-induced neuromuscular blockade with sugammadex in pediatric and adult surgical patients.
Anesthesiology. 2009 Feb; 110(2):284-94.A

Abstract

BACKGROUND

Sugammadex reverses neuromuscular blockade by chemical encapsulation of rocuronium. This phase IIIA study explored efficacy and safety of sugammadex in infants (28 days to 23 months), children (2-11 yr), adolescents (12-17 yr), and adults (18-65 yr).

METHODS

Anesthetized patients (American Society of Anesthesiologists class 1-2) received 0.6 mg/kg rocuronium and were randomized to receive sugammadex (0.5, 1.0, 2.0, or 4.0 mg/kg) or placebo at reappearance of T2. Neuromuscular monitoring was performed using acceleromyography. Primary endpoint was time from sugammadex/placebo administration to recovery of the train-of-four ratio to 0.9. Adverse events and electrocardiograms were recorded, and blood samples were collected for safety and determination of sugammadex and rocuronium plasma concentrations.

RESULTS

A dose-response relation was demonstrated in children (n = 22), adolescents (n = 28), and adults (n = 26), but not infants because of the small sample size (n = 8). After placebo, median recovery time of train-of-four to 0.9 was 21.0, 19.0, 23.4, and 28.5 min in infants, children, adolescents, and adults, respectively. After 2.0 mg/kg sugammadex train-of-four 0.9 was attained in 0.6, 1.2, 1.1, and 1.2 min, respectively. The sugammadex plasma concentrations were similar for the children, adolescent, and adult age groups across the dose range. Sugammadex was well tolerated: No reoccurrence of blockade, inadequate reversal, significant QT prolongation, or other abnormalities were observed.

CONCLUSIONS

Sugammadex is a new reversal agent that rapidly, effectively, safely, and with similar recovery times reverses rocuronium-induced neuromuscular blockade in children, adolescents, adults, and the small number of infants studied.

Authors+Show Affiliations

Department of Anesthesiology and University of Caen Basse-Normandie, Centre Hospitalier Universitaire de Côte-de-Nacre, Caen, France. benoit.plaud@hmn.aphp.frNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19194156

Citation

Plaud, Benoît, et al. "Reversal of Rocuronium-induced Neuromuscular Blockade With Sugammadex in Pediatric and Adult Surgical Patients." Anesthesiology, vol. 110, no. 2, 2009, pp. 284-94.
Plaud B, Meretoja O, Hofmockel R, et al. Reversal of rocuronium-induced neuromuscular blockade with sugammadex in pediatric and adult surgical patients. Anesthesiology. 2009;110(2):284-94.
Plaud, B., Meretoja, O., Hofmockel, R., Raft, J., Stoddart, P. A., van Kuijk, J. H., Hermens, Y., & Mirakhur, R. K. (2009). Reversal of rocuronium-induced neuromuscular blockade with sugammadex in pediatric and adult surgical patients. Anesthesiology, 110(2), 284-94. https://doi.org/10.1097/ALN.0b013e318194caaa
Plaud B, et al. Reversal of Rocuronium-induced Neuromuscular Blockade With Sugammadex in Pediatric and Adult Surgical Patients. Anesthesiology. 2009;110(2):284-94. PubMed PMID: 19194156.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Reversal of rocuronium-induced neuromuscular blockade with sugammadex in pediatric and adult surgical patients. AU - Plaud,Benoît, AU - Meretoja,Olli, AU - Hofmockel,Rainer, AU - Raft,Julien, AU - Stoddart,Peter A, AU - van Kuijk,Jacqueline H M, AU - Hermens,Yvonne, AU - Mirakhur,Rajinder K, PY - 2009/2/6/entrez PY - 2009/2/6/pubmed PY - 2009/3/6/medline SP - 284 EP - 94 JF - Anesthesiology JO - Anesthesiology VL - 110 IS - 2 N2 - BACKGROUND: Sugammadex reverses neuromuscular blockade by chemical encapsulation of rocuronium. This phase IIIA study explored efficacy and safety of sugammadex in infants (28 days to 23 months), children (2-11 yr), adolescents (12-17 yr), and adults (18-65 yr). METHODS: Anesthetized patients (American Society of Anesthesiologists class 1-2) received 0.6 mg/kg rocuronium and were randomized to receive sugammadex (0.5, 1.0, 2.0, or 4.0 mg/kg) or placebo at reappearance of T2. Neuromuscular monitoring was performed using acceleromyography. Primary endpoint was time from sugammadex/placebo administration to recovery of the train-of-four ratio to 0.9. Adverse events and electrocardiograms were recorded, and blood samples were collected for safety and determination of sugammadex and rocuronium plasma concentrations. RESULTS: A dose-response relation was demonstrated in children (n = 22), adolescents (n = 28), and adults (n = 26), but not infants because of the small sample size (n = 8). After placebo, median recovery time of train-of-four to 0.9 was 21.0, 19.0, 23.4, and 28.5 min in infants, children, adolescents, and adults, respectively. After 2.0 mg/kg sugammadex train-of-four 0.9 was attained in 0.6, 1.2, 1.1, and 1.2 min, respectively. The sugammadex plasma concentrations were similar for the children, adolescent, and adult age groups across the dose range. Sugammadex was well tolerated: No reoccurrence of blockade, inadequate reversal, significant QT prolongation, or other abnormalities were observed. CONCLUSIONS: Sugammadex is a new reversal agent that rapidly, effectively, safely, and with similar recovery times reverses rocuronium-induced neuromuscular blockade in children, adolescents, adults, and the small number of infants studied. SN - 1528-1175 UR - https://www.unboundmedicine.com/medline/citation/19194156/Reversal_of_rocuronium_induced_neuromuscular_blockade_with_sugammadex_in_pediatric_and_adult_surgical_patients_ L2 - http://anesthesiology.pubs.asahq.org/article.aspx?doi=10.1097/ALN.0b013e318194caaa DB - PRIME DP - Unbound Medicine ER -