Xenon-anesthesia on Patients Undergoing Major Liver-resection: Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Time-course of postoperative liver injury and function
研究概览
简要总结
The aim of this study is to compare the postoperative outcome of patients undergoing major liver resection under xenon- compared to desflurane-anesthesia.
详细描述
The aim of this study is to compare the postoperative liver function and additional outcome parameters of patients undergoing major liver resection under xenon- compared to desflurane-anesthesia. Xenon is known to maintain hemodynamic stability and consecutive tissue perfusion. Together with its potential for ischemic pre-conditioning, we hypothesize a protective effect of xenon on post-operative liver failure and ischemia/reperfusion injury.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
This trial will be performed double-blinded. After randomization neither the patients nor the investigator of the baseline assessment and the postoperative assessment will be aware of the treatment allocation. The intraoperative anesthesiologist will not be blinded, due to feasibility and safety reasons.
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
- •≥ 3 segments liver resection
- •≥ 18 years
- •Both gender
- •American Society of Anesthesiologists (ASA) classification I-III
- •Written informed consent prior to study participation
排除标准
- •Subjects, fulfilling one or more of the following exclusion criteria will not be included in the study:
- •Severe pulmonary or airway disease
- •Severe liver disease, accompanied by a Child-Pugh class >A
- •Allergy/hypersensitivity to study medications
- •Patients susceptible to malignant hyperthermia
- •Women who are pregnant, breast-feeding or women of childbearing potential not using adequate contraceptive methods
- •Patients with preeclampsia or eclampsia
- •Patients legally unable to give written informed consent.
- •Patients with risk of high oxygen demand
- •Patient with seriously impaired cardiac function
- •All contraindications for xenon anesthesia according to the summary of product characteristics LENOXe
- •Patient participates in a parallel interventional clinical trial during this study or receives an investigational drug within 30 days prior to inclusion into this study
研究组 & 干预措施
Xenon
Xenon concentration of 50-60 % will be used for maintenance of general anesthesia and will be adjusted to maintain Bispectral index (BIS) value between 40 and 60.
干预措施: Xenon (Drug)
Desflurane
Desflurane concentrations of 4-5%/0.8 minimum alveolar concentration (MAC) respectively will be used for maintenance of general anesthesia and will be adjusted to maintain BIS index value between 40 and 60.
干预措施: Desflurane (Drug)
结局指标
主要结局
Time-course of postoperative liver injury and function
时间窗: Within the first 7 postoperative days
The primary study outcome is the difference in postoperative liver injury and function between the two study arms, measured by the perioperative time-course of the liver transaminase alanine-aminotransferase (ALAT) preoperative and on postoperative days (POD) 1-3, 5 and 7.
次要结局
- Necessity and duration of surgical total vascular occlusion(Surgery)
- Expression of tumor necrosis factor (TNF) in the resected liver tissue(Surgery)
- Quantity of intra- and postoperative blood products(Surgery and ICU stay (maximum POD 7))
- Expression of Interleukin 6 (IL-6) in the resected liver tissue(Surgery)
- Expression of fibroblast growth factor (FGF) in the resected liver tissue(Surgery)
- Expression of insulin-like growth factors I/II (IGF-I/II) in the resected liver tissue(Surgery)
- Computer tomography-assisted planimetry of the resected liver tissue(Surgery)
- Time-course of platelet count(Within the first 7 postoperative days)
- Time-course of prothrombin time (PT)(Within the first 7 postoperative days)
- Time-course of partial thromboplastin time (PTT)(Within the first 7 postoperative days)
- Time-course of bilirubin(Within the first 7 postoperative days)
- Time-course of aspartate aminotransferase (ASAT)(Within the first 7 postoperative days)
- Time-course of creatinine(Within the first 7 postoperative days)
- Time-course of lactate(Within the first 7 postoperative days)
- Fibrosis in the resected liver tissue(Surgery)
- Intra- and postoperative blood loss(Surgery and ICU stay (maximum POD 7))
- Time-course of hemoglobin (Hb)(Within the first 7 postoperative days)
- Quantity of intra- and postoperative infusions(Surgery and ICU stay (maximum POD 7))
- Surgery time(Surgery)
- Number of hepatocytes in synthesis phase in the resected liver tissue(Surgery)
- Number of macrophages in the resected liver tissue(Surgery)
- Expression of hepatocyte growth factor (HGF) in the resected liver tissue(Surgery)
- Difference in coagulation disorder, assessed by 30 days follow up via phone(Postoperative day 30)
- Difference in re-admission to hospital, assessed by 30 days follow up via phone(Postoperative day 30)
- Difference in other adverse events, assessed by 30 days follow up via phone(Postoperative day 30)
- Quantity of intra- and postoperative coagulation products(Surgery and ICU stay (maximum POD 7))
- Necessity and duration of surgical pringle maneuver(Surgery)
- Postoperative mortality(Until postoperative day 30)
- Expression of epidermal growth factor (EGF) in the resected liver tissue(Surgery)
- Weight of the resected liver tissue(Surgery)
- Length of ICU stay(Until postoperative day 30)
- Time-course of albumin(Within the first 7 postoperative days)
- Time-course of international normalized ratio (INR)(Within the first 7 postoperative days)
- Postoperative peak of blood lactate(During ICU stay, maximum POD 7)
- Length of hospital stay(Until postoperative day 30)
- Adverse events(Until postoperative day 30)
- Difference in mortality, assessed by 30 days follow up via phone(Postoperative day 30)