Efficacy and Safety of Sugammadex Dosed According to Actual Body Weight (ABW) or Ideal Body Weight (IBW) in Reversal of Neuromuscular Blockade (NMB) in Morbidly Obese Participants (MK-8616-146)
Public ClinicalTrials.gov record NCT03346070. 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 Trial to Study the Efficacy and Safety of Sugammadex (MK-8616) for the Reversal of Neuromuscular Blockade Induced by Either Rocuronium Bromide or Vecuronium Bromide in Morbidly Obese Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this trial is to evaluate the safety and efficacy of Sugammadex when administered according to actual body weight (ABW) as compared to ideal body weight (IBW) for the reversal of both moderate and deep neuromuscular blockade (NMB) induced by either Rocuronium or Vecuronium in morbidly obese participants. The primary hypothesis of this investigation is that, compared to obese participants dosed based on IBW, obese participants receiving Sugammadex according to ABW will demonstrate a faster time to recovery to a Train Of Four (TOF) ratio of ≥0.9 (i.e. faster NMB reversal), pooled across NMB depth and type of neuromuscular blocking agent (NMBA; Rocuronium or Vecuronium) administered.
Study identification
- NCT ID
- NCT03346070
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 207 participants
Conditions and interventions
Conditions
Interventions
- Sugammadex 2 mg/kg ABW Drug
- Sugammadex 2 mg/kg IBW Drug
- Sugammadex 4 mg/kg ABW Drug
- Sugammadex 4 mg/kg IBW Drug
- Neostigmine + Glycopyrrolate Drug
- Rocuronium or 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 31, 2017
- Primary completion
- Jan 28, 2019
- Completion
- Jan 28, 2019
- Last update posted
- Jan 27, 2021
2018 – 2019
United States locations
- U.S. sites
- 13
- U.S. states
- 12
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University California / Davis ( Site 2001) | Sacramento | California | 95817 | — |
| Jackson Memorial Hospital/University of Miami ( Site 2007) | Miami | Florida | 33136 | — |
| University of Kansas Medical Center ( Site 2049) | Kansas City | Kansas | 66160 | — |
| William Beaumont Hospital - Royal Oak ( Site 2033) | Royal Oak | Michigan | 48073 | — |
| University Hospital- Columbia MO ( Site 2060) | Columbia | Missouri | 65212 | — |
| Robert Wood Johnson University Hospital ( Site 2037) | New Brunswick | New Jersey | 08901 | — |
| Mission Hospital - St. Joseph ( Site 2015) | Asheville | North Carolina | 28801 | — |
| Cleveland Clinic Foundation ( Site 2031) | Cleveland | Ohio | 44195 | — |
| Temple University Hospital ( Site 2004) | Philadelphia | Pennsylvania | 19140 | — |
| Vanderbilt University Medical Center ( Site 2032) | Nashville | Tennessee | 37232 | — |
| Hermann Drive Surgical Center ( Site 2020) | Houston | Texas | 77004 | — |
| Hermann Drive Surgical Center ( Site 2059) | Houston | Texas | 77004 | — |
| Zablocki VA Medical Center ( Site 2011) | 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 11 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03346070, 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 Jan 27, 2021 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03346070 live on ClinicalTrials.gov.