Phase 4
Completed N=200
The Effect of Sugammadex Versus Neostigmine on Postoperative Pulmonary Complications
Postoperative Complications · Neuromuscular Blockade
Source: ClinicalTrials.gov NCT02861131 ↗
Enrolled (actual)
200
Serious AEs
2.5%
Results posted
Mar 2020
Primary outcomePrimary: Number of Participants With a Postoperative Pulmonary Complication — 33; 40 Participants
◆ Published Evidence
Highly cited
151citations · ~25 / year
Randomised controlled trial of sugammadex or neostigmine for reversal of neuromuscular block on the incidence of pulmonary complications in older adults undergoing prolonged surgery.
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.
Linked Publications
-
Randomised controlled trial of sugammadex or neostigmine for reversal of neuromuscular block on the incidence of pulmonary complications in older adults undergoing prolonged surgery.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.