Phase 2 Completed N=40 Randomized Supportive Care

Pharmacokinetic-pharmacodynamic Analysis of Sugammadex in Children

Anesthesia, General · Neuromuscular Blockade

Source: ClinicalTrials.gov NCT03943888 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2022

Primary outcomePrimary: Neuromuscular Recovery — 5.7; 3.1; 1.1; 43.7 Minutes

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Neuromuscular Recovery	5.7; 3.1; 1.1; 43.7	—
SECONDARY Plasma Concentrations	28.5; 58.2; 118.9; 5.3; 8.0; 5.4	—

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03943888). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.