Patients with liver-failure undergoing surgery and receiving Rocuronium. Sugammadex is approved for recovery of Rocuronium. There are to date no clinical data to Sugammadex in patients with liver failure.
Conditions
Interventions
Trade Name: BRIDION 100 mg/ml - Injektionsloesung
Product Name: BRIDION 100 mg/ml - Injektionsloesung
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: SUGAMMADEX
CAS Number: 343306-71-8
Sponsors
Medizinische Universität Wien, Univ. Klinik für Anästhesie, Allg. Intensivmedizin u Schmerztherapie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Endstage liver failure and listing for liver transplantations as pointed out by the department of transplantation surgery • Age >18 years • Willingness to participate attested in written consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Known allergic reaction to Sugammadex • Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the time from start of administration of sugammadex to recovery of the TOF ratio to 0.9 in patients with liver failure.;Secondary Objective: To assess the time from start of administration of sugammadex to recovery of the TOF ratio to 0.7 and 0.8 in patients with liver failure. ;Primary end point(s): time from start of administration of sugammadex to recovery of the TOF ratio to 0.9. | — |
Countries
Austria
Outcome results
None listed