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

Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 70
Healthy Volunteers: t
View:

• 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

Locations
United States
Oregon
Oregon Health and Science University
Portland
Time Frame
Start Date: 2017-01-24
Completion Date: 2018-04-30
Participants
Target number of participants: 200
Treatments
Experimental: Sugammadex
Sugammadex 2 mg/kg IV once at the end of surgery
Active_comparator: Neostigmine
Neostigmine 0.07 mg/kg to a maximum of 5 mg (+ Glycopyrrolate 0.1-0.2 mg per 1 mg of Neostigmine administered) IV once at the end of surgery
Sponsors
Collaborators: Merck Sharp & Dohme LLC
Leads: Oregon Health and Science University

This content was sourced from clinicaltrials.gov