Phase 4
N=200
The Effect of Sugammadex Versus Neostigmine on Postoperative Pulmonary Complications
Postoperative Complications · Neuromuscular Blockade
Bottom Line
View on ClinicalTrials.gov: NCT02861131 ↗Enrolled (actual)
200
Serious AEs
2.5%
Results posted
Mar 2020
Primary outcome: Primary: Number of Participants With a Postoperative Pulmonary Complication — 33; 40 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sugammadex (Drug); Neostigmine (Drug)
- Age
- Older Adult · 70+ yrs
- Sex
- All
- Sponsor
- Oregon Health and Science University
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Postoperative Pulmonary Complication |
33; 40 | — |
| SECONDARY Number of Participants With Residual Neuromuscular Blockade in the PACU |
9; 46 | — |
| SECONDARY PACU Phase 1 Recovery Time |
97.3; 110.0 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02861131). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.