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NCT03346057 · ClinicalTrials.gov registry record · Phase 4
Safety of Sugammadex for the Reversal of Neuromuscular Blockade in American Society of Anesthesiologists (ASA) Class 3 or 4 Participants (MK-8616-145)
A Phase 4 study of Reversal of Neuromuscular Blockade, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 4
- Development phase
- 344
- Enrollment target
- 20
- Study locations
NCT03346057 is a Phase 4 study of Reversal of Neuromuscular Blockade that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 344 participants. The trial reports 20 study locations across 16 states.
The verdict
NCT03346057, a Phase 4 study of Reversal of Neuromuscular Blockade, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 344 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Rocuronium
- DRUG Sugammadex 2 mg/kg
- DRUG Sugammadex 4 mg/kg
- DRUG Sugammadex 16 mg/kg
- DRUG Neostigmine + Glycopyrrolate
Study Locations (20)
California
- Loma Linda University Medical Center ( Site 1029) - Loma Linda
- University of California Davis Medical Center ( Site 1001) - Sacramento
Louisiana
- Tulane University ( Site 1057) - New Orleans
- Ochsner Clinic Foundation ( Site 1005) - New Orleans
Missouri
- University Hospital- Columbia MO ( Site 1060) - Columbia
- University of Missouri Health Care ( Site 1022) - Columbia
New Jersey
- Jersey Shore University Medical Center ( Site 1058) - Neptune City
- Saint Peter's University Hospital [New Brunswick, NJ] ( Site 1017) - New Brunswick
Alabama
- University of Alabama - Birmingham ( Site 1046) - Birmingham
Arizona
- University Banner Medical Center ( Site 1019) - Tucson
Florida
- Jackson Memorial Hospital ( Site 1007) - Miami
Kansas
- University of Kansas Medical Center ( Site 1050) - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 344 participants |
| Start Date | 2017-12-20 |
| Est. Completion | 2019-09-04 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03346057
The ClinicalTrials.gov registry entry for NCT03346057 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 344 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 1 condition, with Reversal of Neuromuscular Blockade appearing as the primary indexed condition, and to 5 interventions - of which Rocuronium is the first listed.
NCT03346057 reports 20 study locations spanning 16 distinct geographic areas - top geographies include California, Louisiana, Missouri.
Frequently Asked Questions
What is clinical trial NCT03346057 about?
NCT03346057 is a clinical study titled "Safety of Sugammadex for the Reversal of Neuromuscular Blockade in American Society of Anesthesiologists (ASA) Class 3 or 4 Participants (MK-8616-145)". 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 obj...
What is the current status of trial NCT03346057?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 344 participants. The study started on 2017-12-20. Estimated completion is 2019-09-04.
What conditions does trial NCT03346057 study?
This clinical trial studies the following conditions: Reversal of Neuromuscular Blockade.
What interventions are being tested in trial NCT03346057?
The interventions under investigation include: Rocuronium (DRUG), Sugammadex 2 mg/kg (DRUG), Sugammadex 4 mg/kg (DRUG), Sugammadex 16 mg/kg (DRUG), Neostigmine + Glycopyrrolate (DRUG).
Who is sponsoring clinical trial NCT03346057?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03346057 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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