Impact of Xenon-anesthesia on the Renal Function After Partial Nephrectomy - PaNeX: Partial Nephrectomy Under Xenon:a Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Evaluation of the impact of xenon-anesthesia on the renal function after partial nephrectomy, compared to an isoflurane-anesthesia.
研究概览
简要总结
Purpose of this study is to determine whether Xenon - as compared to Isoflurane - shows a nephroprotection after partial nephrectomy.
详细描述
A partial nephrectomy is accompanied by ischemia time, followed by reperfusion. This frequently leads to a kidney injury of the remained tissue and decrease of the renal function after surgery. As it was shown that Xenon has protective properties against ischemia/reperfusion injury, the investigators hypothesize that Xenon application during partial nephrectomy leads to a stronger nephroprotection than an anesthesia with Isoflurane.
The study will be conducted by two investigator types: The study enrollment and the post-anesthesia follow-up will be performed by Investigator I who is blinded to the study treatment. Investigator II will only perform general anesthesia for partial nephrectomy and will therefore necessarily be unblinded to the treatment conditions.
Patients will be randomly assigned to one of the following study groups. Group 1 (Xenon) will receive Xenon for maintenance of balanced anesthesia for partial nephrectomy. Group 2 (Isoflurane) will receive Isoflurane for the same surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients willing and able to complete the requirements of this study
- •Patients with renal carcinoma restricted to one kidney
- •Patients undergoing partial nephrectomy
- •Men and women >= 18 yrs
- •Informed consent
排除标准
- •Chronic renal failure with a GFR < 60ml/min/1,73m2 body surface area
- •American Society of Anesthesiologists (ASA)>III
- •Hypersensitivity to the study anaesthetics
- •Chronic obstructive pulmonary disease (COPD) GOLD IV
- •Acute coronary syndrome during the last 24 hours; haemodynamic instability, requirement of inotropic support
- •Severe cardial dysfunction New York Heart Association (NYHA) >III
- •Disabling neuropsychiatric disorders
- •Increased intracranial pressure
- •pregnant or breastfeeding women
- •Women of childbearing potential
- •Presumed uncooperativeness or legal incapacity
- •Lack of informed consent
- •Participation in a concomitant trial within the last 30 days
研究组 & 干预措施
Xenon
Gaseous anesthetic, dosage: 60% (v/v) in 40% oxygen, continuous application during surgery
干预措施: Xenon (Drug)
Isoflurane
Inhalative anesthetic, dosage: 1.2% (v/v) in 40% oxygen/medical air , continuous application during surgery
干预措施: Isoflurane (Drug)
结局指标
主要结局
Evaluation of the impact of xenon-anesthesia on the renal function after partial nephrectomy, compared to an isoflurane-anesthesia.
时间窗: Within the first 7 postoperative days
Evaluation of the maximum decrease of glomerular filtration rate (GFR) within 7 days after partial nephrectomy surgery. Maximum decrease will be assessed by the difference between the baseline value of GFR and the minimum value of GFR after surgery.
次要结局
- Secondary efficacy criteria for using xenon-anaesthesia during partial nephrectomy.(Within the first 7 postoperative days)
- Safety criteria for using xenon-anaesthesia during partial nephrectomy.(intraoperative and within the first 7 postoperative days)