Pharmacokinetic-pharmacodynamic Analysis of Sugammadex in Children

• Status: Completed
• Trial end date: 2020-02-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Ministry of Food and Drug Safety, Korea
• Treatments: Atropine; Neostigmine; Rocuronium

Criteria

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