Post-operative Residual Curarization Clinical Trial
Official title:
Sugammadex Versus Neostigmine in Pediatric Day-case Cancer Surgery
The aim of this study was to compare the efficacy of sugammadex and neostigmine on
reversing neuromuscular blockers in pediatric patients undergoing outpatient surgical
procedures.
Postoperative residual curarization (PORC)" a residual duration of action of muscle relaxants
beyond the end of the operation" in postoperative patients is a succession of the presence of
blocked nicotinic receptors. Even in observationally asymptomatic patients, 60-70% of these
receptors can be still blocked. PORC can cause delayed recovery, hypoxia, metabolic
derangement and rarely death. Cholinesterase inhibitors are traditionally used for reversal
of neuromuscular blockade (NMB). Among these agents neostigmine is the most potent and
selective one. Cholinesterase inhibitors have multisystemic side effects. Since these agents
are not selective to nicotinic receptors and also stimulate the muscarinic system, there can
be quite a few serious adverse effects as follows: Bradycardia, QT lengthening,
bronchoconstriction, hypersalivation and increased motility. To avoid these effects,
concomitant anticholinergic agents, such as atropine or glycopyrolate, are administered to
the patient. The incidence of PORC is still high with the prevalence of a train-of-four (TOF)
ratio of less than 0.9 found in the postoperative recovery unit. Recent studies have been
able to link even low levels of residual paralysis (TOF ratio <0.9) with significant
impairment of pharyngeal muscle function, hypoxic ventilatory drive and decreased respiratory
function in the immediate postoperative period.
Despite the knowledge of such side effects, and despite the introduction of various new
neuromuscular blocking agents (NMBA) such as rocuronium or mivacurium over the last 15 years,
no significant reduction in the incidence of residual neuromuscular blockade has so far been
observable.
Today, sugammadex is an alternative to the decurarization procedure, which was traditionally
executed with cholinesterase inhibitors. Sugammadex a γ-cyclodextrin with a high affinity to
rocuronium and other aminosteroidal NMBA that allows the rapid and complete reversal of
especially rocuronium-induced neuromuscular blockade, has raised hopes to overcome the
problem of residual neuromuscular blockade. Sugammadex is proved to be a safe and superior
agent in NMB reversal compared to neostigmine in adults.
PORC and the muscarinic side effects are not anticipated when using sugammadex,.
Also, due to its pharmacodynamic profile, sugammadex, in combination with rocuronium, have
the potential to displace succinylcholine as the "gold standard" muscle relaxant for rapid
sequence induction.
The rudimentary neuromuscular junction, the variability of fibrin fibers, the differences in
drug distribution and body volume in children change their neuromuscular conduction. These
factors can cause prolonged recovery and increased risk of PORC. However, there is few
studies in the literature concerning sugammadex administration in pediatric patients.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02698969 -
Recovery of Muscle Function After Deep Neuromuscular Block by Means of Diaphragm Ultrasonography
|
Phase 4 |