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NCT03346070 · ClinicalTrials.gov registry record · Phase 4
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)
A Phase 4 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 4
- Development phase
- 207
- Enrollment target
NCT03346070 is a Phase 4 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 207 participants.
The verdict
NCT03346070, a Phase 4 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 207 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Neostigmine + Glycopyrrolate
- DRUG Sugammadex 2 mg/kg ABW
- DRUG Sugammadex 2 mg/kg IBW
- DRUG Sugammadex 4 mg/kg ABW
- DRUG Sugammadex 4 mg/kg IBW
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 207 participants |
| Start Date | 2018-01-01 |
| Est. Completion | 2019-01-29 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03346070
The ClinicalTrials.gov registry entry for NCT03346070 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 207 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Neostigmine + Glycopyrrolate is the first listed.
NCT03346070 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03346070 about?
NCT03346070 is a clinical study titled "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)". 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...
What is the current status of trial NCT03346070?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 207 participants. The study started on 2018-01-01. Estimated completion is 2019-01-29.
What interventions are being tested in trial NCT03346070?
The interventions under investigation include: Neostigmine + Glycopyrrolate (DRUG), Sugammadex 2 mg/kg ABW (DRUG), Sugammadex 2 mg/kg IBW (DRUG), Sugammadex 4 mg/kg ABW (DRUG), Sugammadex 4 mg/kg IBW (DRUG).
Who is sponsoring clinical trial NCT03346070?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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