Purpose

This is a randomized, active comparator-controlled, parallel-group, multi-site, double-blind safety trial of sugammadex (MK-8616) for the reversal of neuromuscular blockade (NMB) induced by rocuronium or vecuronium in adult ASA Physical Status Class 3 and 4 participants. The first primary objective of this study is to characterize the incidence of treatment emergent sinus bradycardia, treatment emergent sinus tachycardia, or other treatment emergent cardiac arrhythmias after administration of sugammadex. The second primary objective of this study is to evaluate the general safety of sugammadex in a population of ASA Class 3 and 4 subjects in a surgical setting.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Has a body mass index (BMI) < 40 kg/m2.
  • Is categorized as ASA Physical Status Class 3 or 4, as determined by the Investigator.
  • Has a planned surgical procedure that requires NMB with either rocuronium or vecuronium.
  • Has a planned surgical procedure (e.g., gastrointestinal, urologic, or laparoscopic) that in the opinion of the investigator does not preclude maintenance of moderate or deep depth of NMB throughout the case.
  • If female who is not of reproductive potential, is one of the following: (1) postmenopausal; (2) has had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to screening; (3) has a congenital or acquired condition that prevents childbearing; or (4) is undergoing surgical sterilization (e.g., hysterectomy or tubal ligation) as the planned surgical procedure associated with participation in this study.
  • If female who is sexually active and of child-bearing potential, agrees to use a medically accepted method of contraception through seven days after receiving protocol-specified medication. Abstinence (relative to heterosexual activity) can be used as the sole method of contraception if it is consistently employed as the subject's preferred and usual lifestyle and if considered acceptable by local regulatory agencies and Ethics Review Committees/Institutional Review Boards.
  • Is able to provide (or the participant's legally authorized representative, in accordance with local requirements), written informed consent for the trial. The participant or legally authorized representative may also provide consent for Future Biomedical Research.

Exclusion Criteria

  • Has a pacemaker or automatic implantable cardioverter-defibrillator that precludes the assessment of bradycardia or arrhythmias.
  • Has a medical condition or surgical procedure that precludes reversal of neuromuscular block at the end of surgery.
  • Has a neuromuscular disorder(s) that may affect neuromuscular block and/or trial assessments.
  • Is dialysis-dependent or has severe renal insufficiency (defined as estimated creatinine clearance of <30 mL/min.
  • Has or is suspected of having a personal history or family history (parents, grandparents, or siblings) of malignant hyperthermia.
  • Has or is suspected of having an allergy (e.g., hypersensitivity and/or anaphylactic reaction) to study treatments or its/their excipients, to opioids/opiates, muscle relaxants or their excipients, or other medication(s) used during general anesthesia.
  • Has received or is planned to receive toremifene within 24 hours before or within 24 hours after study medication administration.
  • Has any condition that would contraindicate the administration of study medication.
  • Is pregnant, is attempting to become pregnant, or is lactating.
  • Is currently participating in or has participated in an interventional clinical trial (including any other current or ongoing trial with a sugammadex treatment arm) with an investigational compound or device within 30 days of signing the informed consent form of this current trial.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Sugammadex 2 mg/kg
Sugammadex 2 mg/kg administered as a single intravenous (IV) dose
  • Drug: Sugammadex 2 mg/kg
    Sugammadex 2 mg/kg, administered as a single bolus injection into a fast-running IV line on the day of surgery, for moderate block and reversal in participants receiving the NMBA rocuronium or vecuronium. Moderate block is a level of NMB in which peripheral nerve stimulation elicits one to four muscle twitches.
    Other names:
    • MK-8616
Experimental
Sugammadex 4 mg/kg
Sugammadex 4 mg/kg administered as a single IV dose
  • Drug: Sugammadex 4 mg/kg
    Sugammadex 4 mg/kg, administered as a single bolus injection into a fast-running IV line on the day of surgery, for deep block and reversal in participants receiving the NMBA rocuronium or vecuronium. 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.
    Other names:
    • MK-8616
Experimental
Sugammadex 16 mg/kg
Sugammadex 16 mg/kg administered as a single IV dose
  • Drug: Sugammadex 16 mg/kg
    Sugammadex 16 mg/kg, administered as a single bolus injection into a fast-running IV line on the day of surgery, for deep block and reversal in participants receiving the NMBA rocuronium
    Other names:
    • MK-8616
Active Comparator
Neostigmine + Glycopyrrolate
Neostigmine 50 μg/kg (up to 5 mg maximum dose) plus glycopyrrolate 10 μg/kg (up to 1 mg maximum dose) administered as a single IV dose
  • Drug: Neostigmine + Glycopyrrolate
    Neostigmine 50 μg/kg plus glycopyrrolate 10 μg/kg, administered as a single bolus injection into a fast-running IV line on the day of surgery, for moderate block and reversal in participants receiving the NMBA rocuronium or vecuronium

Recruiting Locations

Tulane University ( Site 1057)
New Orleans, Louisiana 70112
Contact:
Study Coordinator
504-988-5068

More Details

NCT ID
NCT03346057
Status
Recruiting
Sponsor
Merck Sharp & Dohme Corp.

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@merck.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.