Status:
COMPLETED
Pharmacokinetic-pharmacodynamic Analysis of Sugammadex for Conventional Reversal in Children
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Ministry of Food and Drug Safety, Korea
Conditions:
Anesthesia, General
Neuromuscular Blockade
Eligibility:
All Genders
2-17 years
Phase:
PHASE2
Brief Summary
This study administers sugammadex sodium to pediatric patients under general anesthesia with rocuronium. Pharmacokinetic and pharmacodynamic analysis are performed based on plasma concentration of sug...
Detailed Description
This study enrolls pediatric patients undergoing surgery under general anesthesia with need for reversal of neuromuscular blockade, aged between 2 and 18 years old. After routine anesthetic induction...
Eligibility Criteria
Inclusion
- All of below Pediatric patients undergoing surgery under general anesthesia with requirement of early reversal of neuromuscular blockade Aged between 2 and 17 American Society of Anesthesiologists Physical Status Classification 1 and 2
Exclusion
- Any of below One or more legal guardian declines to enroll in the study History of hypersensitivity to any anesthetic agents including rocuronium Presence of underlying cardiovascular or genitourinary disease Under usage of neuromuscular blocking agents before surgery Under usage of drugs influencing the effect of neuromuscular blocking agents History of malignant hyperthermia Anticipation of massive hemorrhage during surgery
Key Trial Info
Start Date :
April 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2021
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04347486
Start Date
April 29 2020
End Date
December 7 2021
Last Update
February 10 2022
Active Locations (1)
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1
SNUH
Seoul, Jongro Gu, South Korea, 15710