At a glance
ClinicalIndex Comparison Record- ✓Age 70 years or older
- ✓Elective surgery scheduled Monday through Friday at OHSU South Operating Rooms
- ✓Planned general endotracheal anesthesia
- ✓Expected surgical duration 3 hours or longer
- ✕Prisoners
- ✕Unable to consent for surgery or anesthesia
- ✕Surgery type where neuromuscular blockade is contraindicated (e.g., neurosurgical, orthopedic, head and neck surgery with nerve monitoring)
- ✕Known neuromuscular disorder
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Effect of Sugammadex Versus Neostigmine on Postoperative Pulmonary Complications in Patients 70 Years or Older and Scheduled for 3 Hour or Longer Surgery-A Randomized Controlled Trial
In Brief
A Phase 4 clinical trial evaluating Sugammadex and Neostigmine for Postoperative Complications and Neuromuscular Blockade. Completed, enrolled 200 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
At the end of the surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Sugammadex will be dosed once at 2 mg/kg through an intravenous line with brisk flow
At the end of surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Neostigmine will be dosed once at 0.07 mg/kg to a maximum of 5 mg through an intravenous line with brisk flow. Glycopyrrolate will be administered with Neostigmine at a dose between 0.1 to 0.2 mg of Glycopyrrolate per 1.0 mg of Neostigmine administered.