Efficacy, Safety, and Pharmacokinetics of Sugammadex for Reversal of Neuromuscular Blockade (NMB) in Pediatric Participants (MK-8616-089)
Public ClinicalTrials.gov record NCT03351608. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 4 Double-Blinded, Randomized, Active Comparator-Controlled Clinical Trial to Study the Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03351608
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 288 participants
Conditions and interventions
Conditions
Interventions
- Sugammadex 2 mg/kg Drug
- Sugammadex 4 mg/kg Drug
- Neostigmine + Glycopyrrolate Drug
- Neostigmine + Atropine Drug
Drug
Eligibility (public fields only)
- Age range
- 2 Years to 16 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 11, 2018
- Primary completion
- Jan 27, 2020
- Completion
- Jan 27, 2020
- Last update posted
- Feb 4, 2021
2018 – 2020
United States locations
- U.S. sites
- 11
- U.S. states
- 8
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Childrens Hospital Los Angeles ( Site 0030) | Los Angeles | California | 90027 | — |
| Lucille Packard Children's Hospital ( Site 0006) | Palo Alto | California | 94304 | — |
| Rady Children's Hospital-San Diego ( Site 0035) | San Diego | California | 92123 | — |
| Children's National Medical Center ( Site 0008) | Washington D.C. | District of Columbia | 20010 | — |
| C.S. Mott Children's Hospital/ University of Michigan Medical center ( Site 0014) | Ann Arbor | Michigan | 48109-4245 | — |
| Saint Peter's University Hospital [New Brunswick, NJ] ( Site 0009) | New Brunswick | New Jersey | 08901 | — |
| Duke University Medical Center ( Site 0019) | Durham | North Carolina | 27710 | — |
| The Children's Hospital of Philadelphia ( Site 0015) | Philadelphia | Pennsylvania | 19104 | — |
| Children's Hospital of Pittsburgh of UPMC ( Site 0005) | Pittsburgh | Pennsylvania | 15224 | — |
| Memorial Hermann Medical Center University of Texas Medical School ( Site 0038) | Houston | Texas | 77030 | — |
| West Virginia University ( Site 0043) | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 19 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03351608, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 4, 2021 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03351608 live on ClinicalTrials.gov.