PKPD of Rocuronium and Sugammadex Profile in Pediatric Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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General Anesthetic Drug Adverse Reaction

Intervention / Treatment
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* Drug: Sugammadex Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group I with dose of Sugammadex of 0.5 Mg/kg<br>After general anesthesia children received one dose of 0.5 Mg/kg of Sugammadex to reverse neuromuscular blockade. | Drug: Sugammadex Injection<br>* 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.<br>* Other names: Sugammadex 100Mg/ml Intravenous Solution;|
| Group II with dose of Sugammadex of 1.0 Mg/kg<br>After general anesthesia children received one dose of 1.0 Mg/kg of Sugammadex to reverse neuromuscular blockade. | Drug: Sugammadex Injection<br>* 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.<br>* Other names: Sugammadex 100Mg/ml Intravenous Solution;|
| Group III with dose of Sugammadex of 2.0 Mg/kg<br>After general anesthesia children received one dose of 2.0 Mg/kg of Sugammadex to reverse neuromuscular blockade. | Drug: Sugammadex Injection<br>* 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.<br>* Other names: Sugammadex 100Mg/ml Intravenous Solution;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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General anesthesia, Children