A Double-blind, Randomized, Parallel Study to Compare the Efficacy of Sugammadex Versus Neostigmine for Reversal of Neuromuscular Blockade at the End of Kidney Transplantation Surgery in Patients With Severe Kidney Dysfunction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Number of Patients With Hypoventilation in Post-anesthesia Care Unit (PACU)
研究概览
简要总结
The purpose of this study is to compare two medications that reverse muscle paralysis at the end of kidney transplant surgery with the goal of reducing residual muscle weakness and insufficient respiratory function after surgery.
详细描述
This is a prospective randomized double-blind single center study on patients with severe kidney failure undergoing kidney transplantation surgery. Patients will have their muscles paralyzed during general anesthesia for surgery. At the end of surgery, muscle paralysis will be reversed with either neostigmine (control group) or sugammadex (intervention group). Residual muscle weakness and respiratory function will be monitored after surgery with a quantitative train-of-four (qTOF) monitor and a noninvasive continuous ventilation monitor. The investigators hypothesize that patients receiving sugammadex will have less residual muscle weakness and better respiratory function than patients receiving neostigmine. Respiratory and kidney function parameters and any adverse events will be collected during the hospital stay. Patients will contacted for a study follow up around 2 weeks after their surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years or older
- •Diagnosed with severe kidney dysfunction (defined by plasma creatinine clearance <30 mL/min)
- •Planning on kidney transplantation surgery at the University of Colorado Hospital.
排除标准
- •Patients unable to sign the informed consent
- •Pregnant women
- •Body Mass Index (BMI) > 40 kg/m2
- •Pre-existing oxygen or ventilatory dependency (24h use of oxygen or other noninvasive or invasive ventilatory support)
- •Patients with any pulmonary, neuromuscular or other disease that severely limits their respiratory functional status (e.g. unable to achieve 4 Metabolic Equivalent of Tasks, METs, such as climbing up 1 flight of stairs)
- •Presence of any contraindication for any of the study-related medications or interventions.
研究组 & 干预措施
Sugammadex
Sugammadex
干预措施: Sugammadex (Drug)
Neostigmine
Neostigmine
干预措施: Neostigmine (Drug)
结局指标
主要结局
Number of Patients With Hypoventilation in Post-anesthesia Care Unit (PACU)
时间窗: Within up to 3 hours after the end of surgery
Presence of one or more episodes of hypoventilation in PACU, adjusted to qTOF and other confounders
次要结局
- Number of Participants With Kidney Graft Dysfunction(Within up to 3 postoperative days and at 14 +/- 3 days after surgery)
- Number of Patients With Presence of qTOF <0.9 in PACU(Within up to 3 hours after the end of surgery)
- Rate of Adverse Events Related to NMBR Medications(Within up to 3 postoperative days)