Efficacy and Safety of Sugammadex Dosed According to Actual Body Weight (ABW) or Ideal Body Weight (IBW) in Reversal of Neuromuscular Blockade (NMB) in Morbidly Obese Participants (MK-8616-146)

PHASE4CompletedINTERVENTIONAL
Enrollment

207

Participants

Timeline

Start Date

January 1, 2018

Primary Completion Date

January 29, 2019

Study Completion Date

January 29, 2019

Conditions
Neuromuscular Blockade
Interventions
DRUG

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."

DRUG

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."

DRUG

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)."

DRUG

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)."

DRUG

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."

DRUG

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.

Trial Locations (24)

1220

Sozialmedizinisches Zentrum Ost - Donauspital ( Site 2150), Vienna

2100

Rigshospitalet ( Site 2253), Copenhagen

2400

Bispebjerg og Frederiksberg Hospital ( Site 2250), Copenhagen NV

2650

Universitaire Ziekenhuis Antwerpen - UZA ( Site 2200), Edegem

19140

Temple University Hospital ( Site 2004), Philadelphia

28801

Mission Hospital - St. Joseph ( Site 2015), Asheville

30625

Diakovere Annastift gGmbH ( Site 2355), Hanover

33136

Jackson Memorial Hospital/University of Miami ( Site 2007), Miami

35043

Universitatsklinikum Giessen und Marburg GmbH ( Site 2356), Marburg

37232

Vanderbilt University Medical Center ( Site 2032), Nashville

44195

Cleveland Clinic Foundation ( Site 2031), Cleveland

48073

William Beaumont Hospital - Royal Oak ( Site 2033), Royal Oak

48145

St. Franziskus-Hospital ( Site 2354), Münster

48231

Josephs-Hospitals Warendorf ( Site 2351), Warendorf

53113

Johanniter Krankenhaus Bonn ( Site 2353), Bonn

53295

Zablocki VA Medical Center ( Site 2011), Milwaukee

65212

University Hospital- Columbia MO ( Site 2060), Columbia

66160

University of Kansas Medical Center ( Site 2049), Kansas City

72764

Klinikum am Steinenberg Reutlingen ( Site 2352), Reutlingen

77004

Hermann Drive Surgical Center ( Site 2020), Houston

Hermann Drive Surgical Center ( Site 2059), Houston

81675

Klinikum Rechts der Isar Technische Universitaet Muenchen ( Site 2350), München

95817

University California / Davis ( Site 2001), Sacramento

08901

Robert Wood Johnson University Hospital ( Site 2037), New Brunswick

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03346070 - Efficacy and Safety of Sugammadex Dosed According to Actual Body Weight (ABW) or Ideal Body Weight (IBW) in Reversal of Neuromuscular Blockade (NMB) in Morbidly Obese Participants (MK-8616-146) | Biotech Hunter | Biotech Hunter