145
Participants
Start Date
July 23, 2019
Primary Completion Date
September 21, 2023
Study Completion Date
September 21, 2023
Sugammadex 2 mg/kg
For moderate NMB reversal, a single IV 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 train-of-four (TOF) stimulations.
Sugammadex 4 mg/kg
For deep NMB reversal, a single IV 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 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 T2 in response to TOF stimulations.
UZ Brussel ( Site 3201), Brussels
Rigshospitalet ( Site 3250), Copenhagen
The Children s Hospital at Westmead ( Site 3805), Westmead
Universitaire Ziekenhuis Antwerpen - UZA ( Site 3200), Edegem
UZ Leuven - Campus Gasthuisberg ( Site 3202), Leuven
Royal Childrens Hospital Melbourne ( Site 3801), Parkville
Debreceni Egyetem Klinikai Kozpont ( Site 4200), Debrecen
Queensland Children s Hospital ( Site 3806), South Brisbane
Szegedi Tudomanyegyetem ( Site 4201), Szeged
Instituto Nacional Cardiovascular Incor ( Site 3928), Lima
Children's Hospital of Pittsburgh UPMC ( Site 3017), Pittsburgh
The Children's Hospital of Philadelphia ( Site 3021), Philadelphia
Centenario Hospital Miguel Hidalgo-Pediatrics Department ( Site 4152), Aguascalientes
Hospital General de Zona No. 1 ( Site 4153), Ciudad de Villa de Álvarez
Variety Children's Hospital D.B.A. Nicklaus Children's Hospital ( Site 3019), Miami
Women and Children Hospital Kuala Lumpur (Hospital Tunku Azizah) ( Site 3875), Kuala Lumpur
C.H.R.U. de Lille. Hopital Jeanne de Flandres ( Site 3304), Lille
University Malaya Medical Centre. ( Site 3876), Kuala Lumpur
OU Medical Center ( Site 3005), Oklahoma City
McGovern Medical School at UT Health/ Memorial Hermann ( Site 3014), Houston
Sarawak General Hospital ( Site 3877), Kuching
Lucille Packard Children's Hospital ( Site 3008), Palo Alto
NMRC Obstetrics Gynecology and Perinatology n.a. V.I. Kulakov ( Site 4287), Moscow
Pediatric Hematology Oncology and Immunology Centre n.a. D.Rogachev. ( Site 4275), Moscow
Children City Clinical Hospital 13 n.a N.F.Filatov ( Site 4285), Moscow
Children City Clinical Hospital #9 n.a. G.N.Speransky ( Site 4290), Moscow
Scientific-Research Clinical Pediatric Institution n.a. Veltischev ( Site 4276), Moscow
St.Petersburg State Pediatric Medical University ( Site 4281), Saint Petersburg
Scientific Research Institute Complex Problems Cardiovascular Disease ( Site 4288), Kemerovo
University of Vermont Medical Center ( Site 3013), Burlington
Hospital Pequeno Principe ( Site 3826), Curitiba
Hospital Tacchini ( Site 3827), Bento Gonçalves
Instituto da Crianca do Hospital das Clinicas-FMUSP ( Site 3825), São Paulo
New Childrens Hospital ( Site 3750), Helsinki
Unidad de Cirugía Cardiovascular ( Site 4126), Guatemala City
Radboud University Medical Center ( Site 4226), Nijmegen
Erasmus University Medical Center ( Site 4225), Rotterdam
University Medical Center Groningen ( Site 4227), Groningen
Wilhelmina Kinderziekenhuis ( Site 4228), Utrecht
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INDUSTRY