Evaluation of the efficacy and safety of sugammadex (Bridion) in children with renal failure. - sugammadex in children with renal failure
- Conditions
- 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: 9.1Level: HLTClassification code 10038443Term: Renal failure and impairmentMedDRA version: 9.1Level: LLTClassification code 10009119Term: Chronic renal failureMedDRA version: 9.1Level: LLTClassification code 10014647Term: End stage renal failure
- Registration Number
- EUCTR2008-008246-20-NL
- Lead Sponsor
- Radboud University Nijmegen Medical Center, Department of Anaesthesiology, Pain and Palliative Medic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method