Reversal of Rocuronium-induced Neuromuscular Blockade with Sugammadex in Pediatric and Adult Surgical Patients

• Published in: Anesthesiology (Philadelphia) 2009-02, Vol.110 (2), p.284-294
• Main Authors: PLAUD, Benoit, MERETOJA, Olli, HOFMOCKEL, Rainer, RAFT, Julien, STODDART, Peter A, VAN KUIJK, Jacqueline H. M, HERMENS, Yvonne, MIRAKHUR, Rajinder K
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Aging - physiology; Androstanols - antagonists & inhibitors; Anesthesia; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Biological and medical sciences; Child; Child, Preschool; Dose-Response Relationship, Drug; Double-Blind Method; Electrocardiography; Female; gamma-Cyclodextrins - adverse effects; gamma-Cyclodextrins - pharmacokinetics; gamma-Cyclodextrins - pharmacology; Humans; Male; Medical sciences; Middle Aged; Monitoring, Intraoperative; Neuromuscular Blockade; Neuromuscular Nondepolarizing Agents - antagonists & inhibitors; Oximetry; Postoperative Complications - epidemiology; Postoperative Nausea and Vomiting - epidemiology; Sample Size; Young Adult
• ISSN: 0003-3022; 1528-1175
• DOI: 10.1097/ALN.0b013e318194caaa

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). 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. 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. 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.