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

Completed · Phase 4

Conditions studied: Reversal of Neuromuscular Blockade

In brief

The purpose of this trial is to evaluate the safety of sugammadex for the reversal of neuromuscular blockade (NMB) induced by neuromuscular blockade agents (NMBA) rocuronium or vecuronium in adult American Society of Anesthesiologists (ASA) Physical Status Class 3 and 4 participants. The primary objectives of the study are to characterize the incidence of treatment emergent sinus bradycardia, treatment emergent sinus tachycardia, or other treatment emergent cardiac arrhythmias after administration of sugammadex and to evaluate the general safety of sugammadex in a population of ASA Class 3 and 4 participants in a surgical setting.

Key facts

Study ID: NCT03346057
Run by: Merck Sharp & Dohme LLC
People needed: 344
Starts: 2017-12-20
Expected to finish: 2019-09-04
Last updated by the study team: 2020-10-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

University of Alabama - Birmingham ( Site 1046) — Birmingham, Alabama, United States
University Banner Medical Center ( Site 1019) — Tucson, Arizona, United States
Loma Linda University Medical Center ( Site 1029) — Loma Linda, California, United States
University of California Davis Medical Center ( Site 1001) — Sacramento, California, United States
Jackson Memorial Hospital ( Site 1007) — Miami, Florida, United States
University of Kansas Medical Center ( Site 1050) — Kansas City, Kansas, United States
Tulane University ( Site 1057) — New Orleans, Louisiana, United States
Ochsner Clinic Foundation ( Site 1005) — New Orleans, Louisiana, United States
Brigham & Women's Hospital ( Site 1039) — Boston, Massachusetts, United States
Beaumont Hospital, Royal Oak ( Site 1034) — Royal Oak, Michigan, United States
University Hospital- Columbia MO ( Site 1060) — Columbia, Missouri, United States
University of Missouri Health Care ( Site 1022) — Columbia, Missouri, United States
Jersey Shore University Medical Center ( Site 1058) — Neptune City, New Jersey, United States
Saint Peter's University Hospital [New Brunswick, NJ] ( Site 1017) — New Brunswick, New Jersey, United States
Mission Hospital - Memorial ( Site 1016) — Asheville, North Carolina, United States
Cleveland Clin Foundation ( Site 1032) — Cleveland, Ohio, United States
Temple University Hospital ( Site 1004) — Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center ( Site 1033) — Nashville, Tennessee, United States
Hermann Drive Surgical Center ( Site 1021) — Houston, Texas, United States
Zablocki VA Medical Center ( Site 1011) — Milwaukee, Wisconsin, United States
A.O. Krankenhaus Dornbirn ( Site 1151) — Dornbirn, Voralberg, Austria
Landeskrankenhaus Feldkirch ( Site 1152) — Feldkirch, Austria
Sozialmedizinisches Zentrum Ost - Donauspital ( Site 1150) — Vienna, Austria
Aarhus Universitets hospital ( Site 1252) — Aarhus, Denmark
Rigshospitalet ( Site 1253) — Copenhagen, Denmark

Full record on ClinicalTrials.gov

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