Status:
COMPLETED
Dialysis of Sugammadex in Participants With Severe Renal Impairment (Study 19.4.333) (P05773)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Neuromuscular Blockade
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Detailed Description
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 minut...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00656799
Start Date
April 1 2008
End Date
July 1 2009
Last Update
March 10 2015
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