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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: Completed Phase 4 study of Reversal of Neuromuscular Blockade, sponsored by Merck Sharp & Dohme.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (34% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The percentage of participants experiencing treatment-emergent sinus bradycardia events was identified with continuous electrocardiogram (ECG) monitoring. Treatment-emergent sinus bradycardia were defined as a heart rate \<60 bpm that has also decreased more than 20% compared to participant baseline heart rate value, sustained for at least 1 minute after administration of study intervention. Treatment-emergent sinus bradycardia events may or may not have been considered an adverse event (AE), as
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 |
What the finished NCT03346057 record still lists
NCT03346057 is an interventional study that assigns participants to a tested intervention. The registered 344 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (34% lower).
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 names 20 study sites across 16 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03346057's enrollment target sits among peer trials
344 245th of 2000 higher than 1,756 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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