The Effect of Sugammadex Versus Neostigmine on Postoperative Pulmonary Complications
Completed · Phase 4
Conditions studied: Postoperative Complications, Neuromuscular Blockade
In brief
Substantial respiratory morbidity has been associated with postoperative residual paralysis, which is fairly common after general anesthesia involving a neuromuscular blocking agent. Common practice in United States is to reverse neuromuscular blockade with neostigmine at the end of surgery. A new drug with evidence of more complete neuromuscular reversal has been developed, sugammadex. The objective of this study is to determine if a strategy of rocuronium neuromuscular reversal with sugammadex will reduce the proportion of subjects with any postoperative pulmonary complication, compared to neostigmine.
Key facts
- Study ID
- NCT02861131
- Run by
- Oregon Health and Science University
- People needed
- 200
- Starts
- 2017-01-24
- Expected to finish
- 2018-04-30
- Last updated by the study team
- 2020-03-31
Who can join
Age: 70 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age ≥ 70 years
- Elective surgery Monday through Friday in the South Operating Rooms of Oregon Health and Science University (OHSU)
- Planned general endotracheal anesthesia
- Expected surgical duration ≥ 3 hours
You may not qualify if…
- Prisoners
- An inability to consent for surgery or anesthesia
- Surgery for which neuromuscular blockade is contraindicated (e.g. neurosurgical, orthopedic, and head and neck surgery in which nerve monitoring will be employed)
- A known neuromuscular disorder
- Stage 4 chronic kidney disease or worse (estimated glomerular filtration rate < 30 ml/min)
- Liver Disease
- An allergies to Sugammadex, Rocuronium, Neostigmine, or Glycopyrrolate
- Patients taking Toremifene
Where it is running
- Oregon Health and Science University — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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