PKPD of Rocuronium and Sugammadex Profile in Pediatric Patients

Optimization of Rocuronium and Sugammadex Dosing Based on Their Pharmacokinetic and Pharmacodynamic (PKPD) Profile in Children Undergoing General Anesthesia

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.

Study Overview

• Status: Completed
• Conditions: General Anesthetic Drug Adverse Reaction
• Intervention / Treatment: Drug: Sugammadex Injection

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 Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• Poland
  • Grand Poland
    • Poznan, Grand Poland, Poland, 60-572
      • Alicja Bartkowska-Sniatkowska

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group I with dose of Sugammadex of 0.5 Mg/kg; After general anesthesia children received one dose of 0.5 Mg/kg of Sugammadex to reverse neuromuscular blockade.	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.; Other Names: Sugammadex 100Mg/ml Intravenous Solution
Group II with dose of Sugammadex of 1.0 Mg/kg; After general anesthesia children received one dose of 1.0 Mg/kg of Sugammadex to reverse neuromuscular blockade.	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.; Other Names: Sugammadex 100Mg/ml Intravenous Solution
Group III with dose of Sugammadex of 2.0 Mg/kg; After general anesthesia children received one dose of 2.0 Mg/kg of Sugammadex to reverse neuromuscular blockade.	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.; Other Names: Sugammadex 100Mg/ml Intravenous Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Investigators: Study Chair: Alicja Bartkowska-Sniatkowska, MD PhD, Department of Pediatric Anesthesiology and Intensive Care

Study record dates

Study Major Dates

• Study Start (Actual): October 27, 2017
• Primary Completion (Actual): January 20, 2020
• Study Completion (Actual): January 29, 2020

Study Registration Dates

• First Submitted: March 7, 2021
• First Submitted That Met QC Criteria: April 18, 2021
• First Posted (Actual): April 20, 2021

Study Record Updates

• Last Update Posted (Actual): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 18, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Children; General anesthesia
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: 161/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: PK and PD data (concentration/effect/time profiles) of individuals will be available
• IPD Sharing Time Frame: The data will be available in 4-6 months and available for 5 years
• IPD Sharing Access Criteria: Scientists
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No