Phase 4
Completed N=288
Efficacy, Safety, and Pharmacokinetics of Sugammadex for Reversal of Neuromuscular Blockade (NMB) in Pediatric Participants (MK-8616-089)
Neuromuscular Blockade
Source: ClinicalTrials.gov NCT03351608 ↗
Enrolled (actual)
288
Serious AEs
2.9%
Results posted
Feb 2021
Primary outcomePrimary: Area Under the Plasma Concentration-Time Curve (AUC) From Dosing to Infinity (AUC0-∞) of Sugammadex [Part A] — 14.1; 18.8; 27.6; 26.9 hr*μg/mL
◆ Published Evidence
Established
25citations · ~6 / year
Sugammadex for reversal of neuromuscular blockade in pediatric patients: Results from a phase IV randomized study.
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 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.
Linked Publications
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Sugammadex for reversal of neuromuscular blockade in pediatric patients: Results from a phase IV randomized study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration-Time Curve (AUC) From Dosing to Infinity (AUC0-∞) of Sugammadex [Part A] |
14.1; 18.8; 27.6; 26.9; 38.2; 49.2 | — |
| PRIMARY Plasma Clearance (CL) of Sugammadex [Part A] |
2.30; 3.58; 4.68; 2.26; 3.43; 5.69 | — |
| PRIMARY Apparent Volume of Distribution (Vz) of Sugammadex [Part A] |
3.58; 6.65; 10.8; 4.00; 8.22; 12.3 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of Sugammadex [Part A] |
17.5; 32.2; 41.3; 47.1; 51.6; 61.9 | — |
| PRIMARY Plasma Half-Life (t½) of Sugammadex [Part A] |
1.15; 1.19; 1.49; 1.12; 1.56; 1.51 | — |
| PRIMARY Percentage of Participants With ≥1 Adverse Event (AE) [Parts A and B] |
97.1; 78.4; 74.9 | — |
| PRIMARY Time to Recovery of Participant Train-of-Four (TOF) Ratio to ≥0.9 [Part B] |
1.6; 1.9; 7.5 | < 0.0001 sig |
| SECONDARY Time to Recovery of Participant TOF Ratio to ≥0.7 [Part B] |
1.1; 1.3; 3.7 | — |
| SECONDARY Time to Recovery of Participant TOF Ratio to ≥0.8 [Part B] |
1.3; 1.5; 5.0 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03351608) and the linked publication. 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. Informational only — not medical advice.