Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants Aged Birth to <2 Years (MK-8616-169)
Public ClinicalTrials.gov record NCT03909165. 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 Aged Birth to <2 Years
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03909165
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 145 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
- 1 Day to 2 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
- Jul 22, 2019
- Primary completion
- Sep 20, 2023
- Completion
- Sep 20, 2023
- Last update posted
- Jul 24, 2025
2019 – 2023
United States locations
- U.S. sites
- 7
- U.S. states
- 6
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Lucille Packard Children's Hospital ( Site 3008) | Palo Alto | California | 94304 | — |
| Variety Children's Hospital D.B.A. Nicklaus Children's Hospital ( Site 3019) | Miami | Florida | 33155 | — |
| OU Medical Center ( Site 3005) | Oklahoma City | Oklahoma | 73104 | — |
| The Children's Hospital of Philadelphia ( Site 3021) | Philadelphia | Pennsylvania | 19104 | — |
| Children's Hospital of Pittsburgh UPMC ( Site 3017) | Pittsburgh | Pennsylvania | 15224 | — |
| McGovern Medical School at UT Health/ Memorial Hermann ( Site 3014) | Houston | Texas | 77030 | — |
| University of Vermont Medical Center ( Site 3013) | Burlington | Vermont | 05401 | — |
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 32 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03909165, 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 Jul 24, 2025 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03909165 live on ClinicalTrials.gov.