General Anesthetic Drug Adverse Reaction
Conditions
Keywords
General anesthesia, Children
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.
Interventions
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.
Sponsors
Poznan University of Medical Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Heart rate [beats per minute] | up to 24 hours | Measurement of the heart rate during and after anesthesia |
| Systolic blood pressure [mmHg] | up to 24 hours | Measurement of the systolic blood pressure during and after anesthesia |
| Sugammadex serum concentration [ng/ml] | up to 24 hours | Different doses of Sugammadex have influence on the pharmacokinetic and pharmacodynamic profile |
| Blood Oxygen Saturation [percent] | up to 24 hours | Measurement of the blood oxygen saturation during and after anesthesia |
| Train-of-four monitoring | through study completion | Standard practice evaluation of muscle strength during anesthesia |
| Diastolic blood pressure [mmHg] | up to 24 hours | Measurement of the diastolic blood pressure during and after anesthesia |
Countries
Poland
Outcome results
None listed