PKPD of Rocuronium and Sugammadex Profile in Pediatric Patients

Completed

• Conditions: General Anesthetic Drug Adverse Reaction
• Interventions: Drug: Sugammadex Injection

• Registration Number: NCT04851574
• Lead Sponsor: Poznan University of Medical Sciences

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.

Study Timeline

• Study Start: 2017-10-27
• Primary Completion: 2020-01-20
• Study Completion: 2020-01-29
• Study First Submitted: 2021-03-07
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-18
• Last Update Submitted: 2021-04-18
• Study First Posted: 2021-04-20
• Last Update Posted: 2021-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group III with dose of Sugammadex of 2.0 Mg/kg	Sugammadex Injection	After general anesthesia children received one dose of 2.0 Mg/kg of Sugammadex to reverse neuromuscular blockade.
Group II with dose of Sugammadex of 1.0 Mg/kg	Sugammadex Injection	After general anesthesia children received one dose of 1.0 Mg/kg of Sugammadex to reverse neuromuscular blockade.
Group I with dose of Sugammadex of 0.5 Mg/kg	Sugammadex Injection	After general anesthesia children received one dose of 0.5 Mg/kg of Sugammadex to reverse neuromuscular blockade.

Primary Outcome Measures

Name	Time	Method
Recovery of muscular contraction following sugammadex injection	up to 24 hours	Recovery of muscular contraction following sugammadex in reversal of neuromuscular blockade in children

Secondary Outcome Measures

Name	Time	Method
Train-of-four monitoring	through study completion	Standard practice evaluation of muscle strength during anesthesia
Sugammadex serum concentration [ng/ml]	up to 24 hours	Different doses of Sugammadex have influence on the pharmacokinetic and pharmacodynamic profile
Systolic blood pressure [mmHg]	up to 24 hours	Measurement of the systolic blood pressure during and after anesthesia
Diastolic blood pressure [mmHg]	up to 24 hours	Measurement of the diastolic blood pressure during and after anesthesia
Blood Oxygen Saturation [percent]	up to 24 hours	Measurement of the blood oxygen saturation during and after anesthesia
Heart rate [beats per minute]	up to 24 hours	Measurement of the heart rate during and after anesthesia

Trial Locations

Locations (1)

Alicja Bartkowska-Sniatkowska; 🇵🇱 Poznan, Grand Poland, Poland