Efficacy, Safety, and Pharmacokinetics of Sugammadex for Reversal of Neuromuscular Blockade (NMB) in Pediatric Participants (MK-8616-089)
Completed · Phase 4
Conditions studied: Neuromuscular Blockade
In brief
This trial will evaluate the efficacy, safety, and pharmacokinetics of sugammadex for the reversal of both moderate and deep neuromuscular blockade (NMB) induced by either rocuronium or vecuronium in pediatric participants. The primary efficacy hypothesis of this investigation is that sugammadex is superior to neostigmine in reversing moderate NMB in pediatric participants as measured by time to recovery to a train-of-four (TOF) ratio of ≥0.9.
Key facts
- Study ID
- NCT03351608
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 288
- Starts
- 2018-02-12
- Expected to finish
- 2020-01-28
- Last updated by the study team
- 2021-02-05
Who can join
Age: 2 and older, up to 16. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Be categorized as American Society of Anesthesiologists (ASA) Physical Status Class 1, 2, or 3.
- Have a planned non-emergent surgical procedure or clinical situation (e.g., intubation) that requires moderate or deep NMB with either rocuronium or vecuronium.
- Have a planned surgical procedure or clinical situation that would allow objective neuromuscular monitoring techniques to be applied with access to the arm for neuromuscular transmission monitoring.
- Age between 2 to <17 years at Visit 2.
- If female, may participate if she is not pregnant, not breastfeeding, and at least one of the following: 1) Not a woman of childbearing potential (WOCBP); or 2) A WOCBP who agrees to follow the study contraceptive guidance during the treatment period and for at least 7 days after the last dose of study treatment.
You may not qualify if…
- Has any clinically significant condition or situation (eg, anatomical malformation that complicates intubation) other than the condition being studied that, in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the trial.
- Has a neuromuscular disorder that may affect NMB and/or trial assessments.
- Is dialysis-dependent or has (or is suspected of having) severe renal insufficiency (defined as estimated glomerular filtration rate (eGFR) <30 ml/min).
- Has or is suspected of having a family or personal history of malignant hyperthermia.
- Has or is suspected of having an allergy 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 and/or fusidic acid via IV administration within 24 hours before or within 24 hours after administration of study treatment.
- Has been previously treated with sugammadex or has participated in a sugammadex clinical trial.
- Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days of signing the informed consent/assent for this current trial.
Where it is running
- Childrens Hospital Los Angeles ( Site 0030) — Los Angeles, California, United States
- Lucille Packard Children's Hospital ( Site 0006) — Palo Alto, California, United States
- Rady Children's Hospital-San Diego ( Site 0035) — San Diego, California, United States
- Children's National Medical Center ( Site 0008) — Washington D.C., District of Columbia, United States
- C.S. Mott Children's Hospital/ University of Michigan Medical center ( Site 0014) — Ann Arbor, Michigan, United States
- Saint Peter's University Hospital [New Brunswick, NJ] ( Site 0009) — New Brunswick, New Jersey, United States
- Duke University Medical Center ( Site 0019) — Durham, North Carolina, United States
- The Children's Hospital of Philadelphia ( Site 0015) — Philadelphia, Pennsylvania, United States
- Children's Hospital of Pittsburgh of UPMC ( Site 0005) — Pittsburgh, Pennsylvania, United States
- Memorial Hermann Medical Center University of Texas Medical School ( Site 0038) — Houston, Texas, United States
- West Virginia University ( Site 0043) — Morgantown, West Virginia, United States
- Sozialmedizinisches Zentrum Ost - Donauspital ( Site 0150) — Vienna, Austria
- Universitaire Ziekenhuis Antwerpen - UZA ( Site 0200) — Edegem, Belgium
- UZ Leuven Campus Gasthuisberg ( Site 0201) — Leuven, Belgium
- Rigshospitalet ( Site 0250) — Copenhagen, Denmark
- New Childrens Hospital ( Site 0750) — Helsinki, Finland
- Diakovere Annastift gGmbH ( Site 0354) — Hanover, Germany
- Universitaetsklinikum Giessen und Marburg GmbH ( Site 0355) — Marburg, Germany
- Klinikum Rechts der Isar Technische Universitaet Muenchen ( Site 0350) — München, Germany
- St. Franziskus-Hospital ( Site 0352) — Münster, Germany
- Klinikum am Steinenberg Reutlingen ( Site 0351) — Reutlingen, Germany
- Josephs-Hospitals Warendorf ( Site 0353) — Warendorf, Germany
- Hospital Santa Lucia ( Site 0501) — Cartagena, Spain
- Hospital Universitario Nino Jesus ( Site 0503) — Madrid, Spain
- Hospital Universitario La Paz ( Site 0502) — Madrid, Spain
Full record on ClinicalTrials.gov
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