Clinical trial NCT04851574: PKPD of Rocuronium and Sugammadex Profile in Pediatric Patients
Official title: Optimization of Rocuronium and Sugammadex Dosing Based on Their Pharmacokinetic and Pharmacodynamic (PKPD) Profile in Children Undergoing General Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: General Anesthetic Drug Adverse Reaction
Keywords: General anesthesia
Children
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 37
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children, aged 2-18 yrs, assessed according to American Society of Anesthesiologists (ASA) scale as I or II, qualified to surgical procedures requiring muscle relaxation for more than 30 minutes, and undergoing general anesthesia

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recovery of muscular contraction following sugammadex injection
timeFrame: up to 24 hours
Secondary outcomes:
measure: Sugammadex serum concentration [ng/ml]
timeFrame: up to 24 hours
measure: Heart rate [beats per minute]
timeFrame: up to 24 hours
measure: Systolic blood pressure [mmHg]
timeFrame: up to 24 hours
measure: Diastolic blood pressure [mmHg]
timeFrame: up to 24 hours
measure: Blood Oxygen Saturation [percent]
timeFrame: up to 24 hours
measure: Train-of-four monitoring
timeFrame: through study completion
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Alicja Bartkowska-Sniatkowska
state: Grand Poland
Study officials:
affiliation: Department of Pediatric Anesthesiology and Intensive Care
name: Alicja Bartkowska-Sniatkowska, MD PhD
role: STUDY_CHAIR
References: