207
Participants
Start Date
January 1, 2018
Primary Completion Date
January 29, 2019
Study Completion Date
January 29, 2019
Sugammadex 2 mg/kg ABW
"Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Sugammadex (2 mg/kg by ABW) for reversal of moderate NMB.~Moderate NMB is defined as the reappearance of a second twitch (T2) in response to TOF stimulations."
Sugammadex 2 mg/kg IBW
"Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Sugammadex (2 mg/kg by IBW) for reversal of moderate NMB.~Moderate NMB is defined as the reappearance of T2 in response to TOF stimulations."
Sugammadex 4 mg/kg ABW
"Following administration of NMBA (Rocuronium or Vecuronium) to achieve deep NMB, participants received a single i.v. bolus of Sugammadex (4 mg/kg by ABW) for reversal of deep NMB.~Deep NMB is defined as no response to TOF stimulations (TOF=0) and a detection target of 1-2 post-tetanic counts (PTCs)."
Sugammadex 4 mg/kg IBW
"Following administration of NMBA (Rocuronium or Vecuronium) to achieve deep NMB, participants will receive a single i.v. bolus of Sugammadex (4 mg/kg by IBW) for reversal of deep NMB.~Deep NMB is defined as no response to TOF stimulations (TOF=0) and a detection target of 1-2 post-tetanic counts (PTCs)."
Neostigmine + Glycopyrrolate
"Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Neostigmine (50 µg/kg; 5 mg maximum) and Glycopyrrolate (10 µg/kg; 1 mg maximum), dosed according to participant ABW for reversal of moderate NMB.~Moderate NMB is defined as the reappearance of T2 in response to TOF stimulations."
Rocuronium or Vecuronium
To achieve NMB, participants received steroidal NMBA Rocuronium Bromide or Vecuronium Bromide administered via i.v. infusion and dosed according to participant ABW. NMBAs were concomitant medications used per label as adjunct to general anesthesia.
Sozialmedizinisches Zentrum Ost - Donauspital ( Site 2150), Vienna
Rigshospitalet ( Site 2253), Copenhagen
Bispebjerg og Frederiksberg Hospital ( Site 2250), Copenhagen NV
Universitaire Ziekenhuis Antwerpen - UZA ( Site 2200), Edegem
Temple University Hospital ( Site 2004), Philadelphia
Mission Hospital - St. Joseph ( Site 2015), Asheville
Diakovere Annastift gGmbH ( Site 2355), Hanover
Jackson Memorial Hospital/University of Miami ( Site 2007), Miami
Universitatsklinikum Giessen und Marburg GmbH ( Site 2356), Marburg
Vanderbilt University Medical Center ( Site 2032), Nashville
Cleveland Clinic Foundation ( Site 2031), Cleveland
William Beaumont Hospital - Royal Oak ( Site 2033), Royal Oak
St. Franziskus-Hospital ( Site 2354), Münster
Josephs-Hospitals Warendorf ( Site 2351), Warendorf
Johanniter Krankenhaus Bonn ( Site 2353), Bonn
Zablocki VA Medical Center ( Site 2011), Milwaukee
University Hospital- Columbia MO ( Site 2060), Columbia
University of Kansas Medical Center ( Site 2049), Kansas City
Klinikum am Steinenberg Reutlingen ( Site 2352), Reutlingen
Hermann Drive Surgical Center ( Site 2020), Houston
Hermann Drive Surgical Center ( Site 2059), Houston
Klinikum Rechts der Isar Technische Universitaet Muenchen ( Site 2350), München
University California / Davis ( Site 2001), Sacramento
Robert Wood Johnson University Hospital ( Site 2037), New Brunswick
Merck Sharp & Dohme LLC
INDUSTRY