The Effect of Sugammadex Versus Neostigmine on Postoperative Pulmonary Complications

• Status: Completed
• Trial end date: 2018-04-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oregon Health and Science University
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Glycopyrrolate; Neostigmine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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