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 Details — Status: Completed

Administrative data

• NCT number: NCT04851574
• Other study ID #: 161/2017
• Status: Completed
• Start date: October 27, 2017
• Est. completion date: January 29, 2020

Study information

• Verified date: April 2021
• Source: Poznan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 29, 2020
• Est. primary completion date: January 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug-Related Side Effects and Adverse Reactions
• General Anesthetic Drug Adverse Reaction

Intervention

Drug:
• Sugammadex Injection
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.

Locations

Country	Name	City	State
Poland	Alicja Bartkowska-Sniatkowska	Poznan	Grand Poland

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery of muscular contraction following sugammadex injection	Recovery of muscular contraction following sugammadex in reversal of neuromuscular blockade in children	up to 24 hours
Secondary	Sugammadex serum concentration [ng/ml]	Different doses of Sugammadex have influence on the pharmacokinetic and pharmacodynamic profile	up to 24 hours
Secondary	Heart rate [beats per minute]	Measurement of the heart rate during and after anesthesia	up to 24 hours
Secondary	Systolic blood pressure [mmHg]	Measurement of the systolic blood pressure during and after anesthesia	up to 24 hours
Secondary	Diastolic blood pressure [mmHg]	Measurement of the diastolic blood pressure during and after anesthesia	up to 24 hours
Secondary	Blood Oxygen Saturation [percent]	Measurement of the blood oxygen saturation during and after anesthesia	up to 24 hours
Secondary	Train-of-four monitoring	Standard practice evaluation of muscle strength during anesthesia	through study completion