Sugammadex is a selective relaxant binding agent, which is administered in case of a rocuronium-induced neuromuscular block, during general anaesthesia. The aim of the trial is to investigate the use, efficacy and safety of sugammadex in children (2-17 years) with moderate to severe renal failure (creatinine clearance < 30 ml/min), compared to children with normal renal function. MedDRA version: 9.1 Level: HLT Classification code 10038443 Term: Renal failure and impairment MedDRA version: 9.1
Conditions
Interventions
Trade Name: Bridion
Product Name: sugammadex, Bridion
Product Code: Org 25969
Pharmaceutical Form: Solution for injection
INN or Proposed INN: sugammadex
Other descriptive name: Bridion
Concentration
Sponsors
Radboud University Nijmegen Medical Center, Department of Anaesthesiology, Pain and Palliative Medic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children with ASA classification status II-III (renal failure) 2. Children with ASA classification status I-II (healthy controls) 3. Age: 2-17 years 4. Scheduled for elective surgical procedures under general anaesthesia, for which a single dose of rocuronium 0.6 mg/kg is needed for endotracheal intubation. 5. Scheduled for surgical procedures in the supine position. 6. Written Informed Consent. 7. Moderate to severe renal failure: creatinine clearance 90 ml/min Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known or suspected neuromuscular disease. 2. Known or suspected malignant hyperthermia. 3. Known or suspected allergy to anaesthetics, muscle relaxants or other medication used during general anaesthesia. 4. Use of medication suspected to interfere with the action of sugammadex (flucloxacillin, fucidinic acid). 5. Use of medication known to interfere with the action of rocuronium (anti-epileptics, aminoglycoside antibriotics, magnesium). 6. Scheduled for outpatient procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of sugammadex in reversing rocuronium-induced neuromuscular blockade in children with moderate to severe renal failure.;Secondary Objective: To demonstrate that sugammadex is safe to use in children with moderate to severe renal failure.;Primary end point(s): Time from start of administration of sugammadex to recovery of the TOF ratio to 0.9 | — |
Countries
Netherlands
Outcome results
None listed