Phase
Condition
Nephropathy
Kidney Failure
Kidney Failure (Pediatric)
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
ASA class 1 - 3 for renally impaired patients, ASA class 1-2 for control group
Age at least 18 years
Scheduled for general anesthesia without further need for muscle relaxation other thanone single dose of 0.6 mg.kg-1 rocuronium
Scheduled for surgical procedures in the supine position
Written informed consent
Creatinine clearance (CLCR) < 30 mL/min for renally impaired group, CLCR = 80 mL/minfor control group
Exclusion
Exclusion Criteria:
Known or suspected neuromuscular disorders impairing NMB
Known or suspected (family) history of malignant hyperthermia
Known or suspected allergy to narcotics, muscle relaxants or other medication usedduring general anesthesia
Use of medication known to interfere with NMBA based on the dose and the time ofadministration, such as antibiotics, anticonvulsants and Mg2+
Pregnancy
Childbearing potential without using any of the following methods of birth control:condom or diaphragm with spermicide, vasectomized partner ( > 6 months), intrauterinedevice, abstinence
Breast-feeding
Prior participation in any trial with Org 25969
Participation in another clinical trial, not pre-approved by NV Organon, within 30days of entering into trial 19.4.304, or for the UK only: Participation in anotherclinical trial, within 30 days of entering into trial 19.4.304.