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PKPD of Rocuronium and Sugammadex Profile in Pediatric Patients

General Anesthetic Drug Adverse Reaction Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

  • Drug-Related Side Effects and Adverse Reactions
  • General Anesthetic Drug Adverse Reaction
Clinical Trial Details
NCT number NCT04851574
Study type Observational
Source Poznan University of Medical Sciences
Contact
Status Completed
Phase
Start date October 27, 2017
Completion date January 29, 2020
View Details
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