A Pharmacokinetic Study of Sugammadex in Dialysis Patients

• Status: Withdrawn
• Trial end date: 2021-09-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tetsuro Sakai

Criteria

Inclusion Criteria:

• Age >18 years

• Currently on hemodialysis renal replacement therapy

• To be undergoing a surgical procedure with the intent of starting hemodialysis postoperatively

• To be undergoing a surgical procedure requiring general anesthesia

• To have neuromuscular blockade for the surgical procedure

Exclusion Criteria:

• Diagnosed with a blood-borne infection (Hepatitis B or C, HIV)

• Allergy to rocuronium or sugammadex

• Planned renal transplant procedure

• Peritoneal dialysis patient

• Starting hemoglobin value of less than 8.0 g/dl

• Women who are currently pregnant