NCT02728726

Sugammadex vs Placebo to Prevent Residual Neuromuscular Block

Randomized Double---Blinded, Controlled Trial to Compare the Effectiveness of Sugammadex vs. Placebo to Prevent Residual Neuromuscular Block in the Post---Anesthesia Care Unit as Evaluated With a Non---Invasive Respiratory Volume Monitor

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The study is designed to determine whether patients who receive sugammadex immediately after tracheal extubation will exhibit a decrease in the incidence of postoperative residual paralysis and an associated decrease in the incidence of postoperative respiratory depression.

Conditions

• General Surgery

Interventions

Type	Name	Description
DRUG	Sugammadex	Sugammadex will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated.
DRUG	Placebo	Placebo will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated.

Timeline

• Start date: 2016-06-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2016-04-05
• Last updated: 2022-07-14
• Results posted: 2022-07-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study