PKPD of Rocuronium and Sugammadex Profile in Pediatric Patients

Poznan University of Medical Sciences (PUMS)

Status: Completed

Conditions: General Anesthetic Drug Adverse Reaction

Treatments: Drug: Sugammadex Injection

Study type: Observational

Funder types: Other

Identifiers

NCT04851574

161/2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

37 participants in 3 patient groups

Group I with dose of Sugammadex of 0.5 Mg/kg

Description:

After general anesthesia children received one dose of 0.5 Mg/kg of Sugammadex to reverse neuromuscular blockade.

Treatment:

Drug: Sugammadex Injection

Group II with dose of Sugammadex of 1.0 Mg/kg

Description:

After general anesthesia children received one dose of 1.0 Mg/kg of Sugammadex to reverse neuromuscular blockade.

Treatment:

Drug: Sugammadex Injection

Group III with dose of Sugammadex of 2.0 Mg/kg

Description:

After general anesthesia children received one dose of 2.0 Mg/kg of Sugammadex to reverse neuromuscular blockade.

Treatment:

Drug: Sugammadex Injection