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

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Bromides; Rocuronium

Criteria

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.