Reversal of Rocuronium-induced Neuromuscular Blockade with Sugammadex in Pediatric and Adult Surgical Patients
| Autor: | Benoit Plaud, Olli A. Meretoja, Yvonne Hermens, Rainer Hofmockel, Julien Raft, Peter A. Stoddart, Jacqueline H. M. van Kuijk, Rajinder K. Mirakhur |
|---|---|
| Rok vydání: | 2009 |
| Předmět: |
Adult
Male Aging Adolescent Edrophonium Postoperative residual curarization Sugammadex Electrocardiography Young Adult 03 medical and health sciences Postoperative Complications 0302 clinical medicine Double-Blind Method 030202 anesthesiology Monitoring Intraoperative medicine Humans Androstanols Oximetry Rocuronium Child Aged Neuromuscular Blockade Dose-Response Relationship Drug business.industry 030208 emergency & critical care medicine Middle Aged medicine.disease Neuromuscular monitoring Neuromuscular Blocking Agents 3. Good health Neostigmine Anesthesiology and Pain Medicine Child Preschool Sample Size Anesthesia Postoperative Nausea and Vomiting Female business Neuromuscular Nondepolarizing Agents gamma-Cyclodextrins medicine.drug |
| Zdroj: | Anesthesiology. 110:284-294 |
| ISSN: | 0003-3022 |
| DOI: | 10.1097/aln.0b013e318194caaa |
| Popis: | 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. NEUROMUSCULAR blocking agents (NMBAs) are frequently used during anesthesia to facilitate tracheal intubation, artificial ventilation, and surgical procedures. Reversal agents (e.g., neostigmine or edrophonium) are often administered to accelerate recovery from neuromuscular blockade and prevent postoperative residual curarization. 1,2 The use of acetylcholinesterase inhibitors, currently the only reversal agents available, is associated with undesirable muscarinic side effects. These side effects necessitate the use of anticholinergic drugs, which may be only partially effective unless used in large doses with possible side effects. In addition, use of acetylcholinesterase inhibitors is associated with residual blockade in both adults and children. 3–7 |
| Databáze: | OpenAIRE |
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