Efficacy, Safety and Pharmacokinetics of Sugammadex (Org 25969; MK-8616) at 3 Different Time Points After 0.6 mg/kg Esmeron® in Male Participants (P05940; MK-8616-020).

Merck Sharp & Dohme (MSD) logo

Merck Sharp & Dohme (MSD)

Status and phase

Completed
Phase 2

Conditions

Neuromuscular Blockade

Treatments

Drug: Placebo
Drug: Sugammadex
Drug: Esmeron®

Study type

Interventional

Funder types

Industry

Identifiers

NCT03519854
19.4.202 (Other Identifier)
MK-8616-020 (Other Identifier)
P05940

Details and patient eligibility

About

This study investigates the efficacy, safety, and pharmacokinetics of sugammadex (Org 25969; MK-8616) when administered for the reversal of neuromuscular blockade in male participants receiving surgery, classified as American Society of Anesthesiologists (ASA) class 1 (otherwise normal, healthy participant) to class 2 (participant with mild systemic disease). The primary objective of this study is to explore the dose-response relation of sugammadex given as a reversal agent at 3, 5, or 15 minutes following administration of 0.6 mg/kg Esmeron®.

Enrollment

99 patients

Sex

Male

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participants of ASA class 1 to 2.
  • Participants scheduled for surgical procedures with an anticipated duration of anesthesia of at least 75 minutes, without further need for muscle relaxation other than for intubation.

Exclusion criteria

  • Participants in whom a difficult intubation because of anatomical malformations is expected.
  • Participants known or suspected to have neuromuscular disorders and/or significant hepatic or renal dysfunction.
  • Participants known or suspected to have a (family) history of malignant hyperthermia.
  • Participants known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia.
  • Participants receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, aminoglycosides, and Mg^2+.
  • Participants who have already participated in this trial.
  • Participants who have participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into this trial.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

99 participants in 18 patient groups, including a placebo group

Arm A. Placebo; given 3 minutes after Esmeron®
Placebo Comparator group
Description:
Placebo (single intravenous (IV) bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Placebo
Arm B. 1 mg/kg Sugammadex; given 3 minutes after Esmeron®
Experimental group
Description:
Sugammadex (1 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm C. 2 mg/kg Sugammadex; given 3 minutes after Esmeron®
Experimental group
Description:
Sugammadex (2 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm D. 4 mg/kg Sugammadex; given 3 minutes after Esmeron®
Experimental group
Description:
Sugammadex (4 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm E. 6 mg/kg Sugammadex; given 3 minutes after Esmeron®
Experimental group
Description:
Sugammadex (6 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm F. 8 mg/kg Sugammadex; given 3 minutes after Esmeron®
Experimental group
Description:
Sugammadex (8 mg/kg; single IV bolus) administered 3 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm G. Placebo; given 5 minutes after Esmeron®
Placebo Comparator group
Description:
Placebo (single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Placebo
Arm H. 1 mg/kg Sugammadex; given 5 minutes after Esmeron®
Experimental group
Description:
Sugammadex (1 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm I. 2 mg/kg Sugammadex; given 5 minutes after Esmeron®
Experimental group
Description:
Sugammadex (2 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm J. 4 mg/kg Sugammadex; given 5 minutes after Esmeron®
Experimental group
Description:
Sugammadex (4 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm K. 6 mg/kg Sugammadex; given 5 minutes after Esmeron®
Experimental group
Description:
Sugammadex (6 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm L. 8 mg/kg Sugammadex; given 5 minutes after Esmeron®
Experimental group
Description:
Sugammadex (8 mg/kg; single IV bolus) administered 5 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm M. Placebo; given 15 minutes after Esmeron®
Placebo Comparator group
Description:
Placebo (single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Placebo
Arm N. 1 mg/kg Sugammadex; given 15 minutes after Esmeron®
Experimental group
Description:
Sugammadex (1 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm O. 2 mg/kg Sugammadex; given 15 minutes after Esmeron®
Experimental group
Description:
Sugammadex (2 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm P. 4 mg/kg Sugammadex; given 15 minutes after Esmeron®
Experimental group
Description:
Sugammadex (4 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm Q. 6 mg/kg Sugammadex; given 15 minutes after Esmeron®
Experimental group
Description:
Sugammadex (6 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex
Arm R. 8 mg/kg Sugammadex; given 15 minutes after Esmeron®
Experimental group
Description:
Sugammadex (8 mg/kg; single IV bolus) administered 15 minutes after the bolus intubation dose of 0.6 mg/kg Esmeron®.
Treatment:
Drug: Esmeron®
Drug: Sugammadex

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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