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Sugammadex vs Placebo to Prevent Residual Neuromuscular Block in PACU
NCT02728726Phase 4
Key facts
- Status
- Completed
- Start
- Jun 2016
- Primary completion
- Dec 2019
- Countries
- 1
- Sponsor
- Mayo Clinic
- Modality
- Biodegradable Polymers, Small Molecules
- Drugs
- Sugammadex
- Conditions
- neuromuscular blockade (NMB)
01
Overview
Phase 4, randomised, double-blind trial in neuromuscular blockade (NMB) comparing Sugammadex with Placebo (2 arms). Primary endpoints: Decreased Minute Ventilation and Decreased Average Minute Ventilation. Started Jun 2016; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Sugammadex
Sugammadex 2 mg/kg IV
Placebo
Placebo 2 mg/kg IV
03
Who it enrols
Patients undergoing surgery with general anesthesia, weighing >= 80 lbs, not intubated prior to surgery, and not anticipated to remain intubated in recovery.
04
Endpoints
Primary
Decreased Minute Ventilation
Decreased Average Minute Ventilation
Secondary
Train of Four Ratio
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