BIS Controlled Anesthesia Depth is Associated With Different Protein and Peptide Expression in the Cerebrospinal Fluid
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Proteome: depression of immune stimulative proteins
研究概览
简要总结
The primary aim of the study is to compare cellular activity of T-cells, NK-cells and monocytes after anesthesia. Phagocytosis and cellular lysis activity of neutrophils and monocytes are analyzed by flow cytometry. Secondly, we analyze anesthesia induced protein expresssion pattern in the blood. The proteome of monocytes is identified by 3D-gel-chromatography and mass spectrometry (MALDI-TOF).
详细描述
Patients undergoing shoulder surgery in the orthopedic center are screened and consented to the randomized controlled, blinded study. Patients, surgeons, and the study personell involved in data interpretation and management are blinded towards the randomly assigned computerized group allocation (SAS, Cary, NC). The study director informs the anesthesiology staff about the group allocation. Patients are randomized to deep vs. light general anesthesia guided using a bispectral index monitor (BIS Vista, Aspect) with BIS < 45 in group 1 (deep anesthesia) or BIS ≥ 55 in group 2 (light anesthesia). Anesthesia depth is recorded via USB port every minute.
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •enrolment for longer shoulder surgery consent for the standard anesthesia form in combination with the interscalene plexus block ASA Status 1-3
排除标准
- •sedative premedication severe immune deficiency (diabetes, steroid or antihistamine medication, cancer, chemotherapy, status post transplantation, drug and alcohol abuse), recent surgery (1 month) or blood transfusion
研究组 & 干预措施
Shallow Anesthesia
Experimental: Shallow Anesthesia Standard anesthesia with fentanyl, propofol for shoulder surgery together with an interscalene plexus block was performed. The anesthesiologist only was informed about the group allocation by the study director and tried to control best for maintenance on target anesthesia level BIS ≥ 55 (group 2, shallow anesthesia). Anesthesia depth as measured by BIS monitors (BIS Vista, Aspect) for every minute and the minutes above a BIS level of 45 were counted.
干预措施: Shallow anesthesia (Drug)
Deep Anesthesia
Experimental: Deep Anesthesia Standard anesthesia with fentanyl, propofol for shoulder surgery together with an interscalene plexus block was performed. The anesthesiologist only was informed about the group allocation by the study director and tried to control best for maintenance on target anesthesia level BIS < 45 (group 1, deep anesthesia). Anesthesia depth as measured by BIS monitors (BIS Vista, Aspect) for every minute and the minutes below a BIS level of 45 were counted.
干预措施: Deep anesthesia (Drug)
结局指标
主要结局
Proteome: depression of immune stimulative proteins
时间窗: 70-90 min
Primary Outcome Measure: 1.Depression of immune stimulating proteins in the proteom of maccrophages in in the 3-D- Gel electrophoresis as given in a percentage from before anesthesia before and following anesthesia period over 60 min
次要结局
- Proteome: overexpression of immune depressive proteins(70-90 min)
研究者
Thomas Frietsch
Associate Professor
Heidelberg University