Last updated on July 2020

Efficacy Safety and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants Aged Birth to <2 Years (MK-8616-169)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Muscle paralysis
  • Age: - 2 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Categorized as American Society of Anesthesiologists (ASA) Physical Status Class 1, 2, or 3.
  • Has a planned non-emergent surgical procedure or clinical situation (e.g., intubation) that requires moderate or deep NMB with either rocuronium or vecuronium.
  • Has a surgical procedure or clinical situation that would allow neuromuscular monitoring techniques to be applied for neuromuscular transmission monitoring.
  • Is male or female, between birth and <2 years of age.

Exclusion Criteria:

  • Is a preterm infant or neonate <36 weeks gestational age at birth.
  • Has any clinically significant condition or situation (e.g., anatomical malformation that complicates intubation) other than the condition requiring the use of NMBA 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.
  • 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.
  • Is expected to require mechanical ventilation after the procedure.
  • 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.
  • Use of medication expected to interfere with study treatments given in this trial.
  • Has been previously treated with sugammadex or has participated in a sugammadex clinical trial within 30 days of signing the informed consent form of this current 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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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