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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:December 20, 2017
End Date:December 26, 2019
Contact:Toll Free Number
Email:Trialsites@merck.com
Phone:1-888-577-8839

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A Phase 4 Randomized, Active-Comparator Controlled Clinical Trial to Study the Safety of Sugammadex (MK-8616) for the Reversal of Neuromuscular Blockade Induced by Either Rocuronium Bromide or Vecuronium Bromide in American Society of Anesthesiologists (ASA) Class 3 or 4 Subjects

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.


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.
We found this trial at
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sites
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Phone: 617-732-2192
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Phone: 205-996-7383
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1500 Northwest 12th Avenue # 106
Miami, Florida 33136
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Phone: 615-322-2564
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Asheville, North Carolina 28801
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Cleveland, Ohio 44195
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3901 Rainbow Blvd
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11234 Anderson St
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Milwaukee, Wisconsin 53295
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3401 N Broad St
Philadelphia, Pennsylvania
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Sacramento, California 95817
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Tucson, Arizona 85724
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