Renal Disease
Conditions
Keywords
Sugammadex, Bridion, hemodialysis, renal disease, rocuronium, Sugammadex-Rocuronium complex
Brief 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.
Interventions
DRUGSugammadex
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.
Sponsors
Tetsuro Sakai
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma sugammadex concentration change from postoperative day 3 or 4 dialysis session and postoperative day 5 or 6 dialysis session | Postoperative day 3 or 4 dialysis session and postoperative day 5 or 6 dialysis session | Plasma samples will be analyzed for concentrations of metabolites in units of microgram/milliliters (mcg/mL). |
| Plasma sugammadex concentration change from day of surgery to postoperative day 1 or 2 dialysis session | Day of surgery and postoperative day 1 or 2 dialysis session | Plasma samples will be analyzed for concentrations of metabolites in units of microgram/milliliters (mcg/mL). |
| Plasma sugammadex concentration change from postoperative day 1 or 2 dialysis to postoperative day 3 or 4 dialysis session | Postoperative day 1 or 2 dialysis session and postoperative day 3 or 4 dialysis session | Plasma samples will be analyzed for concentrations of metabolites in units of microgram/milliliters (mcg/mL). |
| Plasma sugammadex-rocuronium complex concentration change from postoperative day 3 or 4 dialysis session and postoperative day 5 or 6 dialysis session | Postoperative day 3 or 4 dialysis session and postoperative day 5 or 6 dialysis session | Plasma samples will be analyzed for concentrations of metabolites in units of microgram/milliliters (mcg/mL). |
| Plasma sugammadex-rocuronium complex concentration change from day of surgery and postoperative day 1 or 2 dialysis session | Day of surgery and postoperative day 1 or 2 dialysis session | Plasma samples will be analyzed for concentrations of metabolites in units of microgram/milliliters (mcg/mL). |
| Plasma sugammadex-rocuronium complex concentration change from postoperative day 1 or 2 dialysis to postoperative day 3 or 4 dialysis session | Postoperative day 1 or 2 dialysis session and postoperative day 3 or 4 dialysis session | Plasma samples will be analyzed for concentrations of metabolites in units of microgram/milliliters (mcg/mL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants experiencing any number of AEs deemed related to sugammadex drug | Day of surgery through up to post-operative day 10 | Adverse events will be reviewed in the subject electronic medical records (EMR) and relation to the study drug will be determined by the investigator and recorded by research staff. Any untoward medical occurrence resulting from the study drug will be recorded. |
Countries
United States
Outcome results
None listed