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Randomized Double---Blinded, Controlled Trial to Compare the Effectiveness of Sugammadex vs. Placebo to Prevent Residual Neuromuscular Block in the Post---Anesthesia Care Unit as Evaluated With a Non---Invasive Respiratory Volume Monitor
The study is designed to determine whether patients who receive sugammadex immediately after tracheal extubation will exhibit a decrease in the incidence of postoperative residual paralysis and an associated decrease in the incidence of postoperative respiratory depression.
Details
| Lead sponsor | Mayo Clinic |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 260 |
| Start date | 2016-06 |
| Completion | 2019-12 |
Conditions
- General Surgery
Interventions
- Sugammadex
- Placebo
Primary outcomes
- Decreased Minute Ventilation (MV) — 15---30 minutes after Post-anesthesia care unit (PACU) arrival
The number of subjects who have a MV as defined as \[MV \<80% MV predicted (MVPRED) based on Body Surface Area\]. MV (or respiratory minute volume or minute volume) is the volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute. - Decreased Average Minute Ventilation (MV) — 15---30 minutes after Post-anesthesia care unit (PACU) arrival
The number of subjects who have an average MV \<80% MV predicted (MVPRED) based on Body Surface Area. MV (or respiratory minute volume or minute volume) is the volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute.
Countries
United States