MedTrace Logo

Pharmacokinetic-pharmacodynamic Analysis of Sugammadex in Children

NCT03943888 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-11-14

Study results available
· View outcomes & findings →

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.

Conditions

  • Anesthesia, General
  • Neuromuscular Blockade

Interventions

DRUG

Sugammadex Injection 2mg/kg

Intravenous injection of 2mg/kg of sugammadex sodium 15 minutes after rocuronium administration

DRUG

Sugammadex Injection 4mg/kg

Intravenous injection of 4mg/kg of sugammadex sodium 15 minutes after rocuronium administration

DRUG

Sugammadex Injection 8mg/kg

Intravenous injection of 8mg/kg of sugammadex sodium 15 minutes after rocuronium administration

DRUG

Neuromuscular reversal agent injection

Intravenous injection of 0.02mg/kg of atropine and 0.03mg/kg of neostigmine

Sponsors & Collaborators

  • Ministry of Food and Drug Safety, Korea

    collaborator OTHER_GOV

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Hee-Soo Kim, M.D, Ph.D. · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-12
Primary Completion
2020-02-20
Completion
2020-02-20
FDA Drug
Yes

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03943888 on ClinicalTrials.gov