Status:
COMPLETED
Efficacy, Safety, and Pharmacokinetics of Sugammadex for Reversal of Neuromuscular Blockade (NMB) in Pediatric Participants (MK-8616-089)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Neuromuscular Blockade
Eligibility:
All Genders
2-16 years
Phase:
PHASE4
Brief Summary
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 ...
Detailed Description
This trial will be conducted in two parts: Part A and Part B. In Part A, pharmacokinetic (PK) sampling will be conducted to identify the pediatric dose providing sugammadex exposure similar to adults....
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2020
Estimated Enrollment :
288 Patients enrolled
Trial Details
Trial ID
NCT03351608
Start Date
February 12 2018
End Date
January 28 2020
Last Update
February 5 2021
Active Locations (30)
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1
Childrens Hospital Los Angeles ( Site 0030)
Los Angeles, California, United States, 90027
2
Lucille Packard Children's Hospital ( Site 0006)
Palo Alto, California, United States, 94304
3
Rady Children's Hospital-San Diego ( Site 0035)
San Diego, California, United States, 92123
4
Children's National Medical Center ( Site 0008)
Washington D.C., District of Columbia, United States, 20010