Seoul National University Hospital
Seoul, 03080, South Korea
NCT Number: NCT06575036
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.
Trial opening soon.
Get NotifiedUp to 23 month
All sexes
Interventional
Phase 2
Seoul, 03080, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Bridion
Time frame: From start of sugammadex administration to 2 minute after end of administration
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
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
Response to train-of-four stimulation after administration of sugammadex
Time frame: From start of sugammadex administration to 24 hours after end of administration
Incidence of recurarization in the postanesthesia care unit
Time frame: From start of sugammadex administration to discharge from postanesthesia care unit (less than 3 hours)
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 after sugammadex administration measured in the operating room and postanesthesia care unit
Contact information is provided by the study sponsor or research team.
Jung-Bin Park, M.D., Ph.D.
CONTACT
Sang-Hwan Ji, M.D., Ph.D.
CONTACT
Sang-Hwan Ji
Other
Reversal of Rocuronium-induced Neuromuscular Blockade by Sugammadex in Children Younger Than 2 Years Old: a Prospective Dose Finding Study
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