This is a prospective dose-finding study of sugammadex for conventional reversal of rocuronium-induced neuromuscular blockade in children under two years of age. This study will explore 50% effective dose and 95% effective dose of sugammadex for reversal of neuromuscular blockade in less than two minutes under biased coin up-and-down method.
The investigators are planning to enroll 33 patients to obtain data. The starting dose of sugammadex will be 0.5mg/kg. When the dose for a patient was not effective, the dose for next patient will be increased by 0.5mg/kg. When the dose was effective, the dose for next patient will be decreased by 0.5mg/kg or maintained, with a 1:1 of allocation ratio. The investigators will also monitor incidence of any adverse events including residual blockade to evaluate safety of sugammadex in children younger than two years old.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
The starting dose of sugammadex will be 0.5mg/kg. When the dose for a patient was not effective, the dose for next patient will be increased by 0.5mg/kg. When the dose was effective, the dose for next patient will be decreased by 0.5mg/kg or maintained, with a 1:1 of allocation ratio.
Seoul National University Hospital
Seoul, South Korea
50% effective dose
Dose of sugammadex that can reverse neuromuscular blockade in 50% of patients.
Time frame: From start of sugammadex administration to 2 minute after end of administration
95% effective dose
Dose of sugammadex that can reverse neuromuscular blockade in 95% of patients.
Time frame: From start of sugammadex administration to 2 minute after end of administration
TOF result
Response to train-of-four stimulation after administration of sugammadex
Time frame: From start of sugammadex administration to 2 minute after end of administration
Residual blockade
Incidence of recurarization in the postanesthesia care unit
Time frame: From start of sugammadex administration to 24 hours after end of administration
Blood pressure
Noninvasive blood pressure after sugammadex administration measured in the operating room and postanesthesia care unit
Time frame: From start of sugammadex administration to discharge from postanesthesia care unit (less than 3 hours)
Pulse oximetry
Pulse oximetry after sugammadex administration measured in the operating room and postanesthesia care unit
Time frame: From start of sugammadex administration to discharge from postanesthesia care unit (less than 3 hours)
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