Status:
COMPLETED
Comparison of 4.0 mg/kg Sugammadex at 1-2 Post Tetanic Counts (PTC) in Renal or Control Patients (19.4.328)(P05769)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Anesthesia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The current trial was designed to investigate the effects of 4.0 mg.kg-1 of sugammadex on efficacy, safety and pharmacokinetics in subjects with severe renal impairment in comparison to subjects with ...
Detailed Description
The results of previous trials showed that the safety profile of sugammadex observed in subjects with impaired renal function are not appreciably different from subjects with normal renal function. R...
Eligibility Criteria
Inclusion
- At least 18 years of age
- ASA class 1-3
- Creatinine clearance (CLcr) \< 30 mL/min and no anticipated clinical
- indication for high flux hemodialysis during first 24 hours after
- sugammadex administration (for renally impaired group) or CLcr \>= 80
- mL/min (for control group)
- Scheduled for a surgical procedure under general anesthesia with propofol
- requiring neuromuscular relaxation with the use of rocuronium
- Scheduled for a surgical procedure in supine position
- Written informed consent
Exclusion
- \- Subjects known or suspected to have neuromuscular disorders impairing
- neuromuscular blockade and/or significant hepatic dysfunction
- Subjects scheduled for renal transplant surgery
- Subjects known or suspected to have a (family) history of malignant
- hyperthermia
- Subjects known or suspected to have an allergy to narcotics, muscle
- relaxants or other medication used during general anesthesia
- Subjects receiving fusidic acid, toremifene and/or flucloxacillin
- Subjects who have already participated in a sugammadex trial
- Subjects who have participated in another clinical trial, not pre-approved
- by the sponsor, within 30 days of entering into 19.4.328 (P05769)
- Female subjects who are pregnant
- Female subjects who are breast-feeding
Key Trial Info
Start Date :
September 24 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2010
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT00702715
Start Date
September 24 2008
End Date
March 15 2010
Last Update
May 16 2017
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