Assessing the Post-Surgical Trend of Sugammadex Concentration in Dialysis Dependent Patients
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Plasma sugammadex concentration change from postoperative day 3 or 4 dialysis session and postoperative day 5 or 6 dialysis session
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Sugammadex (Drug)
结局指标
主要结局
Plasma sugammadex concentration change from postoperative day 3 or 4 dialysis session and postoperative day 5 or 6 dialysis session
时间窗: 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 postoperative day 3 or 4 dialysis session and postoperative day 5 or 6 dialysis session
时间窗: 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
时间窗: 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
时间窗: 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 day of surgery to postoperative day 1 or 2 dialysis session
时间窗: 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
时间窗: 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).
次要结局
- Number of participants experiencing any number of AEs deemed related to sugammadex drug(Day of surgery through up to post-operative day 10)
研究者
Tetsuro Sakai
Professor, Anesthesiology and Perioperative Medicine
University of Pittsburgh