Reversal of rocuronium-induced neuromuscular blockade with sugammadex in pediatric and adult surgical patients.
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.
Plaud
Benoît
B
Department of Anesthesiology and University of Caen Basse-Normandie, Centre Hospitalier Universitaire de Côte-de-Nacre, Caen, France. benoit.plaud@hmn.aphp.fr
Meretoja
Olli
O
Hofmockel
Rainer
R
Raft
Julien
J
Stoddart
Peter A
PA
van Kuijk
Jacqueline H M
JH
Hermens
Yvonne
Y
Mirakhur
Rajinder K
RK
D000293:Adolescent; D000328:Adult; D000368:Aged; D000375:Aging / Q000502:physiology; D000732:Androstanols / Q000037:antagonists & inhibitors*; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004562:Electrocardiography; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016343:Monitoring, Intraoperative; D019148:Neuromuscular Blockade; D003473:Neuromuscular Nondepolarizing Agents / Q000037:antagonists & inhibitors*; D010092:Oximetry; D011183:Postoperative Complications / Q000453:epidemiology; D020250:Postoperative Nausea and Vomiting / Q000453:epidemiology; D000077123:Rocuronium; D018401:Sample Size; D000077122:Sugammadex; D055815:Young Adult; D047408:gamma-Cyclodextrins / Q000009:adverse effects / Q000493:pharmacokinetics / Q000494:pharmacology*
D000732:Androstanols; D003473:Neuromuscular Nondepolarizing Agents; D047408:gamma-Cyclodextrins; D000077122:Sugammadex; D000077123:Rocuronium