Dialysis of Sugammadex in Participants With Severe Renal Impairment (Study 19.4.333) (P05773)

A Single Center, Open-Label Trial in Subjects With Severe Renal Impairment Evaluating the Dialysability of the Sugammadex-Rocuronium Complex

The clinical trial objectives were to evaluate the dialysability of the sugammadex-rocuronium complex; it's safety and efficacy in participants with severe renal impairment.

The current trial was designed to evaluate the dialysability of the sugammadex-rocuronium complex in participants with severe renal impairment. A dose of 4.0 mg/kg sugammadex was administered 15 minutes after administration of 0.6 mg/kg rocuronium. Blood and dialysate samples were collected before, during and after hemodialysis/filtration, for calculation of clearance of sugammadex-rocuronium complex and assessment of rebound.

Inclusion Criteria:

• At least 18 years of age
• American Society of Anesthesiologists (ASA) Class >=4
• Creatinine clearance (CLCR) < 30 mL/min and clinical indication for dialysis
• Hospitalization at Intensive Care Unit (ICU) and scheduled for a (surgical) procedure under general anesthesia requiring neuromuscular relaxation with the use of rocuronium
• Scheduled for a (surgical) procedure in supine position
• Written informed consent (of the legal representative)

Exclusion Criteria:

• Known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant hepatic dysfunction
• Known or suspected to have a (family) history of malignant hyperthermia
• Known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia
• Have already participated in a sugammadex trial
• Have participated in another clinical trial, not preapproved by NV Organon, within 30 days of study entry
• Females who are pregnant*
• Females who are breast-feeding * In females pregnancy will be excluded both from medical history and by a human chorionic gonadotropin (hCG) test within 24 hours before surgery except in females who are not of childbearing potential, i.e. at least 2 years menopausal or have undergone tubal ligation or an hysterectomy.