CompletedNot Applicable

PKPD of Rocuronium and Sugammadex Profile in Pediatric Patients

Poland37 participantsStarted 2017-10-27

Plain-language summary

The aim of the study is to assess the pharmacokinetic and pharmacodynamic properties of rocuronium and sugammadex and their clinical effect in the terms of both the relaxation of paralysed muscles (rocuronium) and the reversal of neuromuscular blockade (sugammadex) in children over 2 years of age undergoing general anesthesia for surgical procedures needing muscle relaxation for more than 30 minutes.

Who can participate

Age range2 Years – 18 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: * age 2-18 years * ASA I-II * qualification to surgival procedures requiring muscle relaxation for more than 30 minutes * parental consent of children below 16 yrs and parental and child's consent if child was older than 16 yrs of age * Bioethical Commission approvement No 161/17 Exclusion Criteria: * ASA III and more * age below 2 yrs * lack of consent * allergy to studied drugs * less than 30 minutes of relaxation required

What they're measuring

Recovery of muscular contraction following sugammadex injection

Timeframe: up to 24 hours

Trial details

NCT IDNCT04851574

SponsorPoznan University of Medical Sciences

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-01-20

View on ClinicalTrials.gov More General Anesthetic Drug Adverse Reaction trials