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Pharmacokinetic-pharmacodynamic Analysis of Sugammadex for Conventional Reversal in Children

NCT04347486 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-02-10

No results posted yet for this study

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 on reappearance of T2

DRUG

Sugammadex Injection 4mg/kg

Intravenous injection of 4mg/kg of sugammadex sodium on reappearance of T2

DRUG

Sugammadex Injection 8mg/kg

Intravenous injection of 8mg/kg of sugammadex sodium on reappearance of T2

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
2020-04-29
Primary Completion
2021-12-07
Completion
2021-12-07
FDA Drug
Yes

Countries

  • South Korea

Study Locations

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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 NCT04347486 on ClinicalTrials.gov