Safety of Sugammadex for the Reversal of Neuromuscular Blockade in American Society of Anesthesiologists (ASA) Class 3 or 4 Participants (MK-8616-145)
Public ClinicalTrials.gov record NCT03346057. 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 Randomized, Active-Comparator Controlled Clinical Trial to Study the Safety of Sugammadex (MK-8616) for the Reversal of Neuromuscular Blockade Induced by Either Rocuronium Bromide or Vecuronium Bromide in American Society of Anesthesiologists (ASA) Class 3 or 4 Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this trial is to evaluate the safety of sugammadex for the reversal of neuromuscular blockade (NMB) induced by neuromuscular blockade agents (NMBA) rocuronium or vecuronium in adult American Society of Anesthesiologists (ASA) Physical Status Class 3 and 4 participants. The primary objectives of the study are to characterize the incidence of treatment emergent sinus bradycardia, treatment emergent sinus tachycardia, or other treatment emergent cardiac arrhythmias after administration of sugammadex and to evaluate the general safety of sugammadex in a population of ASA Class 3 and 4 participants in a surgical setting.
Study identification
- NCT ID
- NCT03346057
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 344 participants
Conditions and interventions
Conditions
Interventions
- Sugammadex 2 mg/kg Drug
- Sugammadex 4 mg/kg Drug
- Sugammadex 16 mg/kg Drug
- Neostigmine + Glycopyrrolate Drug
- Rocuronium Drug
- Vecuronium Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Dec 20, 2017 (Actual)
- Primary completion
- Sep 4, 2019 (Actual)
- Completion
- Sep 4, 2019 (Actual)
- Last update posted
- Oct 8, 2020
2017 – 2019
United States locations
- U.S. sites
- 20
- U.S. states
- 16
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama - Birmingham ( Site 1046) | Birmingham | Alabama | 35233 | — |
| University Banner Medical Center ( Site 1019) | Tucson | Arizona | 85719 | — |
| Loma Linda University Medical Center ( Site 1029) | Loma Linda | California | 92354 | — |
| University of California Davis Medical Center ( Site 1001) | Sacramento | California | 95817 | — |
| Jackson Memorial Hospital ( Site 1007) | Miami | Florida | 33136 | — |
| University of Kansas Medical Center ( Site 1050) | Kansas City | Kansas | 66160 | — |
| Tulane University ( Site 1057) | New Orleans | Louisiana | 70112 | — |
| Ochsner Clinic Foundation ( Site 1005) | New Orleans | Louisiana | 70121 | — |
| Brigham & Women's Hospital ( Site 1039) | Boston | Massachusetts | 02115 | — |
| Beaumont Hospital, Royal Oak ( Site 1034) | Royal Oak | Michigan | 48073 | — |
| University Hospital- Columbia MO ( Site 1060) | Columbia | Missouri | 65212 | — |
| University of Missouri Health Care ( Site 1022) | Columbia | Missouri | 65212 | — |
| Jersey Shore University Medical Center ( Site 1058) | Neptune City | New Jersey | 07753 | — |
| Saint Peter's University Hospital [New Brunswick, NJ] ( Site 1017) | New Brunswick | New Jersey | 08901 | — |
| Mission Hospital - Memorial ( Site 1016) | Asheville | North Carolina | 28801 | — |
| Cleveland Clin Foundation ( Site 1032) | Cleveland | Ohio | 44195 | — |
| Temple University Hospital ( Site 1004) | Philadelphia | Pennsylvania | 19140-5103 | — |
| Vanderbilt University Medical Center ( Site 1033) | Nashville | Tennessee | 37232 | — |
| Hermann Drive Surgical Center ( Site 1021) | Houston | Texas | 77004 | — |
| Zablocki VA Medical Center ( Site 1011) | Milwaukee | Wisconsin | 53295 | — |
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 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03346057, 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 Oct 8, 2020 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03346057 live on ClinicalTrials.gov.