Neuromuscular Blockade
Conditions
Keywords
Sugammadex, Children, Dose-finding study
Brief summary
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.
Detailed description
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.
Interventions
DRUGSugammadex
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.
Sponsors
Sang-Hwan Ji
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Up-and-down dose finding method using biased coin design
Eligibility
Sex/Gender
ALL
Age
No minimum to 23 Months
Healthy volunteers
No
Inclusion criteria
* Childern younger than 2 years old who are scheduled to undergo surgery under general anesthesia * American Society of Anesthesiologists Physical Status 1 or 2
Exclusion criteria
* History of hypersensitivity to rocuronium or any anesthetics * Presence of cardiovascular or genitourinary disease * Presence of severe renal dysfunction or in need of dialysis * Presence of severe hepatic dysfunction or coagualtion disorder * Current state of administration of neuromuscular blocking agent on admission to operating room * Concurrent use of any medications that affect the activity of neuromuscular blocking agents * History of malignant hyperthermia * Refusal to enroll in the study by one or more parents * Presence of any other reasons that investigator regards inappropriate to enroll in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 50% effective dose | From start of sugammadex administration to 2 minute after end of administration | Dose of sugammadex that can reverse neuromuscular blockade in 50% of patients. |
| 95% effective dose | From start of sugammadex administration to 2 minute after end of administration | Dose of sugammadex that can reverse neuromuscular blockade in 95% of patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TOF result | From start of sugammadex administration to 2 minute after end of administration | Response to train-of-four stimulation after administration of sugammadex |
| Residual blockade | From start of sugammadex administration to 24 hours after end of administration | Incidence of recurarization in the postanesthesia care unit |
| Blood pressure | 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 |
| Pulse oximetry | 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 |
Countries
South Korea
Contacts
Primary ContactSang-Hwan Ji, M.D., Ph.D.
Backup ContactJung-Bin Park, M.D., Ph.D.
Outcome results
None listed