344
Participants
Start Date
December 20, 2017
Primary Completion Date
September 4, 2019
Study Completion Date
September 4, 2019
Sugammadex 2 mg/kg
Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Sugammadex 2 mg/kg for reversal of moderate NMB. Moderate block is a level of NMB in which peripheral nerve stimulation elicits one to four muscle twitches.
Sugammadex 4 mg/kg
Following administration of NMBA (Rocuronium or Vecuronium) to achieve deep NMB, participants received a single i.v. bolus of Sugammadex 4 mg/kg for reversal of deep NMB. Deep block is a level of NMB in which peripheral nerve stimulation elicits no muscle twitches and high-frequency muscle stimulation elicits minimal levels of muscle contraction.
Sugammadex 16 mg/kg
Following administration of NMBA (Rocuronium) to achieve deep NMB, participants received a single i.v. bolus of Sugammadex 16 mg/kg for reversal of deep NMB. Deep block is a level of NMB in which peripheral nerve stimulation elicits no muscle twitches and high-frequency muscle stimulation elicits minimal levels of muscle contraction.
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) for reversal of moderate NMB. Moderate block is a level of NMB in which peripheral nerve stimulation elicits one to four muscle twitches.
Rocuronium
To achieve NMB, participants received steroidal NMBA Rocuronium Bromide administered via IV infusion and dosed according to participant body weight. NMBAs were concomitant medications used per label and at Investigator's discretion as an adjunct to general anesthesia.
Vecuronium
To achieve NMB, participants received steroidal NMBA Vecuronium Bromide administered via IV infusion and dosed according to participant body weight. NMBAs were concomitant medications used per label and at Investigator's discretion as an adjunct to general anesthesia.
Sozialmedizinisches Zentrum Ost - Donauspital ( Site 1150), Vienna
Rigshospitalet ( Site 1253), Copenhagen
Bispebjerg og Frederiksberg Hospital ( Site 1250), Copenhagen NV
Landeskrankenhaus Feldkirch ( Site 1152), Feldkirch
A.O. Krankenhaus Dornbirn ( Site 1151), Dornbirn
Aarhus Universitets hospital ( Site 1252), Aarhus
Regionshospitalet Viborg ( Site 1254), Viborg
Mission Hospital - Memorial ( Site 1016), Asheville
Jackson Memorial Hospital ( Site 1007), Miami
University of Alabama - Birmingham ( Site 1046), Birmingham
Vanderbilt University Medical Center ( Site 1033), Nashville
Cleveland Clin Foundation ( Site 1032), Cleveland
Beaumont Hospital, Royal Oak ( Site 1034), Royal Oak
Josephs-Hospitals Warendorf ( Site 1351), Warendorf
Zablocki VA Medical Center ( Site 1011), Milwaukee
University Hospital- Columbia MO ( Site 1060), Columbia
University of Missouri Health Care ( Site 1022), Columbia
University of Kansas Medical Center ( Site 1050), Kansas City
Tulane University ( Site 1057), New Orleans
Ochsner Clinic Foundation ( Site 1005), New Orleans
Klinikum am Steinenberg Reutlingen ( Site 1352), Reutlingen
Hermann Drive Surgical Center ( Site 1021), Houston
Klinikum Rechts der Isar Technische Universitaet Muenchen ( Site 1350), München
University Banner Medical Center ( Site 1019), Tucson
Loma Linda University Medical Center ( Site 1029), Loma Linda
University of California Davis Medical Center ( Site 1001), Sacramento
Brigham & Women's Hospital ( Site 1039), Boston
Jersey Shore University Medical Center ( Site 1058), Neptune City
Saint Peter's University Hospital [New Brunswick, NJ] ( Site 1017), New Brunswick
Temple University Hospital ( Site 1004), Philadelphia
Merck Sharp & Dohme LLC
INDUSTRY