Evaluation of the efficacy and safety of sugammadex (Bridion) in children with renal failure. - sugammadex in children with renal failure

Radboud University Nijmegen Medical Center, Department of Anaesthesiology, Pain and Palliative Medic0 个研究点目标入组 20 人开始时间: 2009年1月14日最近更新: 2022年8月8日

适应症

试验速览

暂无简介。

•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 < 30 ml/min.
•8.Healthy controls: 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

•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.

发起方

Radboud University Nijmegen Medical Center, Department of Anaesthesiology, Pain and Palliative Medic