Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Bloc… (NCT03909165) | Clinical Trial Compass
CompletedPhase 4
Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants Aged Birth to <2 Years (MK-8616-169)
United States145 participantsStarted 2019-07-23
Plain-language summary
This study will evaluate the efficacy, safety, and pharmacokinetics (PK) of sugammadex (MK-8616) for reversal of both moderate and deep neuromuscular blockade (NMB) in pediatric participants aged birth to \<2 years. The primary hypothesis of this study is that sugammadex is superior to neostigmine in reversing moderate NMB as measured by time to neuromuscular recovery.
Who can participate
Age range1 Day – 2 Years
SexALL
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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 2…
What they're measuring
1
Part A: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0-inf) for Sugammadex
Timeframe: Day 1: 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose
2
Part A: Area Under the Plasma Concentration Time Curve up to the Interpolated Concentration at 1 Hour Post Dose (AUC0-1hr) for Sugammadex
Timeframe: Day 1: 2, 15, 30, and 60 minutes (1 hour) post-dose
3
Part A: Area Under the Plasma Concentration Time Curve up to the Interpolated Concentration at 4 Hours Post Dose (AUC0-4hr) for Sugammadex
Timeframe: Day 1: 2, 15, 30, 60, and 240 minutes (4 hours) post-dose
4
Part A: Maximum Plasma Concentration (Cmax) of Sugammadex
Timeframe: Day 1: 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose
5
Part A: Plasma Clearance (CL) of Sugammadex
Timeframe: Day 1: 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose
6
Part A: Apparent Volume of Distribution (Vd) for Sugammadex
Timeframe: Day 1: 2, 15, 30, 60, 240 to 360, and 600 to 720 minutes post-dose
7
Apparent Volume of Distribution at Steady State (Vss) for Sugammadex