Optimization of Rocuronium and Sugammadex Dosing Based on Their Pharmacokinetic and Pharmacodynamic (PKPD) Profile in Children Undergoing General Anesthesia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Recovery of muscular contraction following sugammadex injection
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 2 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age 2-18 years
- •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
Arms & Interventions
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.
Intervention: Sugammadex Injection (Drug)
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.
Intervention: Sugammadex Injection (Drug)
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.
Intervention: Sugammadex Injection (Drug)
Outcomes
Primary Outcomes
Recovery of muscular contraction following sugammadex injection
Time Frame: up to 24 hours
Recovery of muscular contraction following sugammadex in reversal of neuromuscular blockade in children
Secondary Outcomes
- Train-of-four monitoring(through study completion)
- Sugammadex serum concentration [ng/ml](up to 24 hours)
- Systolic blood pressure [mmHg](up to 24 hours)
- Diastolic blood pressure [mmHg](up to 24 hours)
- Blood Oxygen Saturation [percent](up to 24 hours)
- Heart rate [beats per minute](up to 24 hours)
Investigators
Agnieszka Bienert
Full Professor
Poznan University of Medical Sciences