NCT04556721

A Pharmacokinetic Study of Sugammadex in Dialysis Patients

Assessing the Post-Surgical Trend of Sugammadex Concentration in Dialysis Dependent Patients

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Tetsuro Sakai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this prospective study is to assess the trend of sugammadex (and its complex with rocuronium) concentration in surgical patients with routine outpatient hemodialysis. Patients with end stage renal disease who are to receive general anesthesia and muscle paralysis will have their paralysis by rocuronium reversed with sugammadex. Patients will then have blood drawn during their next three routine hemodialysis sessions to assess for the plasma concentration of sugammadex or the sugammadex-rocuronium complex over time.

Detailed description

Patients with end-stage renal disease often have several additional comorbidities and stand to benefit immensely from this established superior drug. Prior studies have not been able to correlate negative adverse events with sugammadex in patients with end-stage renal disease. More work needs to be done, however, to assess the fate of this renally excreted molecule. It has been shown that there is potential to clear sugammadex with high flux dialysis. We hypothesize that post-surgical patients with end-stage renal disease will see a significant decrease in plasma sugammadex concentration after routine outpatient dialysis.

Conditions

• Renal Disease

Interventions

Type	Name	Description
DRUG	Sugammadex	On the day of surgery, after the establishment of general anesthesia, patients will be paralyzed via rocuronium. At the cessation of the case, an appropriate dose of Sugammadex will be utilized to reverse the rocuronium neuromuscular blockade.

Timeline

• Start date: 2021-09-10
• Primary completion: 2021-09-10
• Completion: 2021-09-10
• First posted: 2020-09-21
• Last updated: 2021-09-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study