Skip to main content
OpenTrials
Completed

NCT Number: NCT04851574

PKPD of Rocuronium and Sugammadex Profile in Pediatric Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

General Anesthetic Drug Adverse Reaction

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Alicja Bartkowska-Sniatkowska

Poznan, Grand Poland, 60-572, Poland

About this study

The study group was divided into three subgroups depending on the different doses of sugammadex. Group I received dose of 0.5 Mg/kg, Group II - 1.0 Mg/kg and Group III received dose of 2 Mg/kg of sugammadex. General anesthesia was performed among all included patients at the same way. During general anesthesia monitoring of TOF - Train-of-four, was used to assess the muscle relaxation force of rocuronium as well as the reversal of neuromuscular blockade by sugammadex. For this purpose, 1.5 ml of blood samples taken 8 times, were collected to determine the PKPD of the tested drugs, according to own protocol.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sugammadex injection

Drug

Sugammadex was administered in the dose of 0.5 Mg/kg or 1.0 Mg/kg or 2.0 Mg/kg to reverse neuromuscular blockade.

Other names: Sugammadex 100Mg/ml Intravenous Solution

Primary outcomes

  1. Recovery of muscular contraction following sugammadex injection

    Time frame: up to 24 hours

    Recovery of muscular contraction following sugammadex in reversal of neuromuscular blockade in children

Secondary outcomes

  1. Sugammadex serum concentration [ng/ml]

    Time frame: up to 24 hours

    Different doses of Sugammadex have influence on the pharmacokinetic and pharmacodynamic profile

  2. Heart rate [beats per minute]

    Time frame: up to 24 hours

    Measurement of the heart rate during and after anesthesia

  3. Systolic blood pressure [mmHg]

    Time frame: up to 24 hours

    Measurement of the systolic blood pressure during and after anesthesia

  4. Diastolic blood pressure [mmHg]

    Time frame: up to 24 hours

    Measurement of the diastolic blood pressure during and after anesthesia

  5. Blood Oxygen Saturation [percent]

    Time frame: up to 24 hours

    Measurement of the blood oxygen saturation during and after anesthesia

  6. Train-of-four monitoring

    Time frame: through study completion

    Standard practice evaluation of muscle strength during anesthesia

Sponsors and collaborators

Lead sponsor

Poznan University of Medical Sciences

Other

Registry information

Official study title

Optimization of Rocuronium and Sugammadex Dosing Based on Their Pharmacokinetic and Pharmacodynamic (PKPD) Profile in Children Undergoing General Anesthesia

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 20, 2021
Registry last updated
Apr 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.