Phase 4
N=145
Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants Aged Birth to <2 Years (MK-8616-169)
Neuromuscular Blockade
Bottom Line
View on ClinicalTrials.gov: NCT03909165 ↗Enrolled (actual)
145
Serious AEs
4.4%
Results posted
Sep 2024
Primary outcome: Primary: Part A: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0-inf) for Sugammadex — 13.40; 16.22; 11.50; 14.07 Hour (hr)*ug/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sugammadex 2 mg/kg (Drug); Sugammadex 4 mg/kg (Drug); Neostigmine + Glycopyrrolate (Drug); Neostigmine + Atropine (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part A: Area Under the Plasma Concentration Time Curve From Time Zero to Infinity (AUC0-inf) for Sugammadex |
13.40; 16.22; 11.50; 14.07; 39.09; 31.90 | — |
| PRIMARY Part A: Area Under the Plasma Concentration Time Curve up to the Interpolated Concentration at 1 Hour Post Dose (AUC0-1hr) for Sugammadex |
6.95; 7.63; 6.10; 7.31; 12.38; 14.39 | — |
| PRIMARY Part A: Area Under the Plasma Concentration Time Curve up to the Interpolated Concentration at 4 Hours Post Dose (AUC0-4hr) for Sugammadex |
10.68; 13.99; 10.13; 12.57; 27.79; 27.16 | — |
| PRIMARY Part A: Maximum Plasma Concentration (Cmax) of Sugammadex |
19.59; 21.18; 19.39; 20.99; 28.56; 30.38 | — |
| PRIMARY Part A: Plasma Clearance (CL) of Sugammadex |
0.43; 0.66; 1.28; 1.34; 0.35; 0.61 | — |
| PRIMARY Part A: Apparent Volume of Distribution (Vd) for Sugammadex |
1.14; 1.45; 2.68; 2.70; 1.22; 1.35 | — |
| PRIMARY Apparent Volume of Distribution at Steady State (Vss) for Sugammadex |
1.04; 1.23; 2.07; 2.14; 1.11; 1.18 | — |
| PRIMARY Part A: Half-Life (t1/2) of Sugammadex in Plasma |
1.84; 1.52; 1.45; 1.40; 2.39; 1.53 | — |
| PRIMARY Part B: Time to Neuromuscular Recovery (TTNMR) In Reversal of Moderate Block |
1.4; 4.4 | = 0.0002 sig |
| PRIMARY Parts A and B: Percentage of Participants With Adverse Events (AEs) Up To 7 Days Post Administration of Study Medication |
68.2; 68.3; 61.3 | — |
| SECONDARY Part B: Time to Extubation In Reversal of Moderate Block |
7.9; 10.5 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03909165). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.