The aim of this study is to estimate the optimal dose of sugammadex and neostigmine reversal of a vecuronium-induced residual neuromuscular block at train-of-four ratio 0.3.
Sugammadex is a modified γ-cyclodextrin compound that reverses the neuromuscular blockade produced by steroidal nondepolarizing muscle relaxants such as rocuronium,vecuronium and pipecuronium by encapsulating them, making them unavailable to interact with the nicotinic acetylcholine receptors at the neuromuscular junction.However, residual neuromuscular blocks between reappearance of T4 and train-of-four ratio (TOFR)=0.5 are more frequent in clinical practice compared with profound or deep blocks and have not been investigated for sugammadex previously. Unlike neostigmine, sugammadex is efficacious in reversing profound (no responses to either train-of-four (TOF) or posttetanic count stimulation) or deep (posttetanic count of 1 or 2) neuromuscular block (NMB) in doses of 16 and 4 mg/kg, respectively. However, shallow neuromuscular blocks are more frequent in clinical practice compared with profound or deep blocks and have not been investigated for sugammadex previously.
Study Type
OBSERVATIONAL
Enrollment
121
At the end of surgical procedure at a depth of neuromuscular blockade at the reappearance of train-of-four 0.3, single intravenous injection of either : Sugammadex 0.125 mg/kg (sugammadex 0.125) Sugammadex 0.25 mg/kg (sugammadex 0.25) Sugammadex 0.5 mg/kg (sugammadex 0.5) Sugammadex 1.0 mg/kg (sugammadex 1.0) Sugammadex 2.0 mg/kg (sugammadex 2.0)
At the end of surgical procedure at a depth of neuromuscular blockade at the reappearance of train-of-four 0.3, single intravenous injection of either : Neostigmine 10 µg/kg (Neostigmine 10) Neostigmine 25 µg/kg (Neostigmine 25) Neostigmine 40 µg/kg (Neostigmine 40) Neostigmine 55 µg/kg (Neostigmine 55) Neostigmine 70 µg/kg (Neostigmine 70) Atropine will be administered with Neostigmine at a half dose of Neostigmine administered through an intravenous line with brisk flow.
Guangzhou Military Region General Hospital, Department of Anesthesiology
Guangzhou, Guangdong, China
Time to TOF 0.9 after the administration of reversal agent
The time to achieve TOF (Train of Four stimulation) ratio to 0.9 following the investigational drug or placebo administration.
Time frame: the general anesthesia time 1 hour at least
incidence of reparalysis
Determining whether patients receiving reversal agent will have a train-to-four ratio \<0.8 during total recovery time (from TOF reach 0.9 first time to post-anaesthesia care unit (PACU) departure)
Time frame: approximately 1 hour
incidence of adverse event
Documenting whether patients will have some adverse events(such as hypoxia bradycardia nausea and vomiting) from anesthesia commence to PACU departure.
Time frame: the general anesthesia and recovery time 2 hours at least
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At the end of surgical procedure at a depth of neuromuscular blockade at the reappearance of train-of-four 0.3, single intravenous injection of saline 0.9%.