CompletedPhase 2

Pharmacokinetic-pharmacodynamic Analysis of Sugammadex in Children

South Korea40 participantsStarted 2019-08-12

Plain-language 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 sugammadex sodium and monitoring of neuromuscular blockade.

Who can participate

Age range2 Years – 17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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 Criteria: 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

What they're measuring

Neuromuscular Recovery

Timeframe: up to 30 minutes to 1 hour

Trial details

NCT IDNCT03943888

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-20

Results submitted2022-10-20

View on ClinicalTrials.gov More Anesthesia, General trials