Risk of Acute Complications With Rocuronium vs Cisatracurium in Patients With Chronic Kidney Disease
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 490
- 试验地点
- 2
- 主要终点
- Post Operative Pulmonary Complications (PPCs)
研究概览
简要总结
The purpose of the study is to determine which combination of neuromuscular blocking agent and reversal agent is safer to use during anesthesia for patients with chronic kidney disease. The main question it aims to answer is
"The use of Cisatracurium with neostigmine leads to less post-operative pulmonary complications than Rocuronium with sugammadex."
详细描述
Participants will be randomized into one of the two groups (Group 1-Given rocuronium and sugammadex as part of one of the standard regimens of neuromuscular blockade and reversal or Group 2-Given cisatracurium and neostigmine as part of one of the standard regimens of neuromuscular blockade and reversal).
Both of which are current standard of care practices. Appropriate reversal will be performed and documented, and the patient will go to the recovery room or intensive care unit as planned preoperatively. The patients will be assessed postoperatively for up to 7 days for any signs of respiratory complications, including but not limited to:
- Atelectesis
- Hypoxia
- Respiratory distress/failure
- Pneumonia
- Pneumothrax
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject is able and willing to provide and sign informed consent
- •The subject must be between 18 and 80 years of age
- •The subject should have chronic kidney disease as defined by glomerular filtration rate
- •The surgery must require general anesthesia with endotracheal intubation and neuromuscular blockade
排除标准
- •Any patient under the age of 18
- •Any patient over the age of 80
- •Any patient with end stage renal disease
- •Any patient requiring dialysis
- •Patients presenting for Renal Transplantation
- •Pregnant Female
- •Any patient in the correctional system
- •Urgent or Emergent procedure
- •The surgery requires intubation post-operatively
- •Documented allergy to Rocuronium, Sugammadex, Cisatracurium or Neostigmine
研究组 & 干预措施
Rocuronium and Sugammadex (RS) Group
The participants will be given rocuronium and sugammadex as part of one of the standard regimens of neuromuscular blockade and reversal.
干预措施: Rocuronium (Drug)
Rocuronium and Sugammadex (RS) Group
The participants will be given rocuronium and sugammadex as part of one of the standard regimens of neuromuscular blockade and reversal.
干预措施: Sugammadex (Drug)
Cisatracurium and Neostigmine (CN) Group
The participants will be given cisatracurium and neostigmine as part of one of the standard regimens of neuromuscular blockade and reversal.
干预措施: Cisatracurium (Drug)
Cisatracurium and Neostigmine (CN) Group
The participants will be given cisatracurium and neostigmine as part of one of the standard regimens of neuromuscular blockade and reversal.
干预措施: Neostigmine (Drug)
结局指标
主要结局
Post Operative Pulmonary Complications (PPCs)
时间窗: 7 days
PPCs will be scored using a grading scale where 0 = no complication, 1 = mild, 2 = moderate, and 3 = severe complication, with 0 as the minimum score and 3 as the maximum score.
次要结局
- Hospital Length of Stay(7 days)
- Post Anesthesia Care Unit (PACU) length of stay(7 days)
- Number of patients with cardiac instability(7 days)