PKPD of Rocuronium and Sugammadex Profile in Pediatric Patients

Poznan University of Medical Sciences37 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

General Anesthetic Drug Adverse Reaction

Interventions

Sugammadex InjectionDRUG

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.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Alicja Bartkowska-Sniatkowska

Poznan, Grand Poland, Poland

Outcomes

Primary Outcomes

Recovery of muscular contraction following sugammadex injection

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

Time frame: up to 24 hours

Secondary Outcomes

Sugammadex serum concentration [ng/ml]

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

Time frame: up to 24 hours

Heart rate [beats per minute]

Measurement of the heart rate during and after anesthesia

Time frame: up to 24 hours

Systolic blood pressure [mmHg]

Measurement of the systolic blood pressure during and after anesthesia

Time frame: up to 24 hours

Diastolic blood pressure [mmHg]

Measurement of the diastolic blood pressure during and after anesthesia

Time frame: up to 24 hours

Blood Oxygen Saturation [percent]

Measurement of the blood oxygen saturation during and after anesthesia

Time frame: up to 24 hours

Train-of-four monitoring

Standard practice evaluation of muscle strength during anesthesia

Time frame: through study completion

Data from ClinicalTrials.gov

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