Safety of Sugammadex for the Reversal of Neuromuscular Blockade in American Society of Anesthesiologists (ASA) Class 3 or 4 Participants (MK-8616-145)

PHASE4CompletedINTERVENTIONAL
Enrollment

344

Participants

Timeline

Start Date

December 20, 2017

Primary Completion Date

September 4, 2019

Study Completion Date

September 4, 2019

Conditions
Reversal of Neuromuscular Blockade
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

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) for reversal of moderate NMB. Moderate block is a level of NMB in which peripheral nerve stimulation elicits one to four muscle twitches.

DRUG

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.

DRUG

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.

Trial Locations (30)

1220

Sozialmedizinisches Zentrum Ost - Donauspital ( Site 1150), Vienna

2100

Rigshospitalet ( Site 1253), Copenhagen

2400

Bispebjerg og Frederiksberg Hospital ( Site 1250), Copenhagen NV

6800

Landeskrankenhaus Feldkirch ( Site 1152), Feldkirch

6850

A.O. Krankenhaus Dornbirn ( Site 1151), Dornbirn

8200

Aarhus Universitets hospital ( Site 1252), Aarhus

8800

Regionshospitalet Viborg ( Site 1254), Viborg

28801

Mission Hospital - Memorial ( Site 1016), Asheville

33136

Jackson Memorial Hospital ( Site 1007), Miami

35233

University of Alabama - Birmingham ( Site 1046), Birmingham

37232

Vanderbilt University Medical Center ( Site 1033), Nashville

44195

Cleveland Clin Foundation ( Site 1032), Cleveland

48073

Beaumont Hospital, Royal Oak ( Site 1034), Royal Oak

48231

Josephs-Hospitals Warendorf ( Site 1351), Warendorf

53295

Zablocki VA Medical Center ( Site 1011), Milwaukee

65212

University Hospital- Columbia MO ( Site 1060), Columbia

University of Missouri Health Care ( Site 1022), Columbia

66160

University of Kansas Medical Center ( Site 1050), Kansas City

70112

Tulane University ( Site 1057), New Orleans

70121

Ochsner Clinic Foundation ( Site 1005), New Orleans

72764

Klinikum am Steinenberg Reutlingen ( Site 1352), Reutlingen

77004

Hermann Drive Surgical Center ( Site 1021), Houston

81675

Klinikum Rechts der Isar Technische Universitaet Muenchen ( Site 1350), München

85719

University Banner Medical Center ( Site 1019), Tucson

92354

Loma Linda University Medical Center ( Site 1029), Loma Linda

95817

University of California Davis Medical Center ( Site 1001), Sacramento

02115

Brigham & Women's Hospital ( Site 1039), Boston

07753

Jersey Shore University Medical Center ( Site 1058), Neptune City

08901

Saint Peter's University Hospital [New Brunswick, NJ] ( Site 1017), New Brunswick

19140-5103

Temple University Hospital ( Site 1004), Philadelphia

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03346057 - Safety of Sugammadex for the Reversal of Neuromuscular Blockade in American Society of Anesthesiologists (ASA) Class 3 or 4 Participants (MK-8616-145) | Biotech Hunter | Biotech Hunter