288
Participants
Start Date
February 12, 2018
Primary Completion Date
January 28, 2020
Study Completion Date
January 28, 2020
Sugammadex 2 mg/kg
For moderate NMB reversal, a single i.v. bolus of sugammadex (2 mg/kg) will be given after final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
Sugammadex 4 mg/kg
For deep NMB reversal, a single i.v. bolus of sugammadex (4 mg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0).
Neostigmine + Glycopyrrolate
For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 μg/kg; up to 5 mg maximum dose) as well as glycopyrrolate (10 μg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
Neostigmine + Atropine
For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 μg/kg; up to 5 mg maximum dose) as well as atropine (20 μg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
Sozialmedizinisches Zentrum Ost - Donauspital ( Site 0150), Vienna
Rigshospitalet ( Site 0250), Copenhagen
Universitaire Ziekenhuis Antwerpen - UZA ( Site 0200), Edegem
UZ Leuven Campus Gasthuisberg ( Site 0201), Leuven
Children's Hospital of Pittsburgh of UPMC ( Site 0005), Pittsburgh
Uludag Universitesi Tip Fakultesi ( Site 0553), Bursa
The Children's Hospital of Philadelphia ( Site 0015), Philadelphia
Children's National Medical Center ( Site 0008), Washington D.C.
West Virginia University ( Site 0043), Morgantown
Duke University Medical Center ( Site 0019), Durham
Hospital Universitario Nino Jesus ( Site 0503), Madrid
Hospital Universitario La Paz ( Site 0502), Madrid
Hospital Santa Lucia ( Site 0501), Cartagena
Diakovere Annastift gGmbH ( Site 0354), Hanover
Clinica Universitaria de Navarra ( Site 0500), Pamplona
Koc Universitesi Hastanesi ( Site 0555), Istanbul
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0552), Istanbul
Universitaetsklinikum Giessen und Marburg GmbH ( Site 0355), Marburg
St. Franziskus-Hospital ( Site 0352), Münster
Josephs-Hospitals Warendorf ( Site 0353), Warendorf
Klinikum am Steinenberg Reutlingen ( Site 0351), Reutlingen
Memorial Hermann Medical Center University of Texas Medical School ( Site 0038), Houston
Klinikum Rechts der Isar Technische Universitaet Muenchen ( Site 0350), München
Childrens Hospital Los Angeles ( Site 0030), Los Angeles
Rady Children's Hospital-San Diego ( Site 0035), San Diego
Lucille Packard Children's Hospital ( Site 0006), Palo Alto
C.S. Mott Children's Hospital/ University of Michigan Medical center ( Site 0014), Ann Arbor
Saint Peter's University Hospital [New Brunswick, NJ] ( Site 0009), New Brunswick
New Childrens Hospital ( Site 0750), Helsinki
Ankara Universitesi Tip Fakultesi ( Site 0551), Ankara
Merck Sharp & Dohme LLC
INDUSTRY