A Pharmacokinetic Study of Sugammadex in Dialysis Patients

Sponsor

Tetsuro Sakai (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04556721

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Disease	Drug: Sugammadex	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 10, 2021

Actual Primary Completion Date :

Sep 10, 2021

Actual Study Completion Date :

Sep 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sugammadex After surgery and general anesthesia, a clinically-appropriate dose of Sugammadex will be utilized to reverse the rocuronium neuromuscular blockade. Either 2 mg/kg or 4 mg/kg dosing will be used based on the level of neuromuscular blockade at the time of reversal. Administer as single IV bolus injection infused over 10 seconds into existing IV line. Dose is based on actual body weight (mg/kg).	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. Other Names: Bridion

Arm

Intervention/Treatment

Experimental: Sugammadex

After surgery and general anesthesia, a clinically-appropriate dose of Sugammadex will be utilized to reverse the rocuronium neuromuscular blockade. Either 2 mg/kg or 4 mg/kg dosing will be used based on the level of neuromuscular blockade at the time of reversal. Administer as single IV bolus injection infused over 10 seconds into existing IV line. Dose is based on actual body weight (mg/kg).

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.

Other Names:

Bridion

Outcome Measures

Primary Outcome Measures

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 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).
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).

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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