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 range

2 Years – 18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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