Phase 3
Completed N=68
Comparison of 4.0 mg/kg Sugammadex at 1-2 Post Tetanic Counts (PTC) in Renal or Control Patients (19.4.328)(P05769)
Source: ClinicalTrials.gov NCT00702715 ↗Enrolled (actual)
68
Serious AEs
17.7%
Results posted
Apr 2011
Primary outcomePrimary: Time to Recovery of the T4/T1 Ratio to 0.9. — 205; 112 seconds
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 normal renal function.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Recovery of the T4/T1 Ratio to 0.9. |
205; 112 | — |
| SECONDARY Time to Recovery of the T4/T1 Ratio to 0.8 |
169; 90 | — |
| SECONDARY Time to Recovery of T4/T1 Ratio to 0.7 |
144; 79 | — |
Eligibility Criteria
Inclusion Criteria
- At least 18 years of age
- ASA class 1-3
- Creatinine clearance (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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00702715). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.