Hypnotic Depth Reduces Lymphocyte Proliferation to Natural Killer Cells, B-cells, Memory T-cells, Depresses Intracellular Oxidative Burst and Changes Protein Expression Pattern of Monocytes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Depression of lymphocyte proliferation by CD expression pattern in SASPA-Test as given in a percentage from before anesthesia
研究概览
简要总结
Anesthesia depth affects the proliferation of lymphocytes to NK-cells and memory T-cells effect and the phagocytosis activity of macrophages in healthy patients. ASA 1-3 subjects undergoing extended shoulder surgery under continuous regional anesthesia randomly were assigned to a deep or a shallow anesthesia level (BIS <35 or >55) for more than an hour. Immune response is measured by lymphocyte proliferation as well as neutrophil and monocyte phagocytosis activity.
详细描述
Blood samples were taken under minimal stress prior to anesthesia induction (T0), recovery (T1) and 12 weeks following hospital discharge (T2) from the respective anesthesia depth level. Bispectral index monitoring (BIS) was performed from the awake state to complete recovery in all subjects.
Hemoglobin concentration, leukocyte and lymphocyte counts were determined by routine automated laboratory techniques. Lymphocyte proliferation was analyzed by SASPA flow cytometry analysis. In brief, 100 µl EDTA blood were stirred with 10 µl FITC and PE marked antibody mixture containing CD3, CD4, CD8, CD 16, CD45, CD28, CD27, CD 56.
Monocyte and neutrophil phagocytosis activity was measured separately in macrophages of fresh heparinized whole blood using flow cytometric test kits.
Proteomics of monocytes was done synchronously.
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
Deep Anesthesia
Standard anesthesia with fentanyl, propofol for shoulder surgery together with a 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 was measured by BIS monitors (BIS Vista, Aspect) for every minute and the minutes below or equal to a BIS level of 45 were counted.
干预措施: High dose propofol, fentanyl and sevoflurane (Drug)
Shallow Anesthesia
Standard anesthesia with fentanyl, propofol for shoulder surgery together with a inter scalene 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: Low dose propofol, fentanyl and sevoflurane (Drug)
结局指标
主要结局
Depression of lymphocyte proliferation by CD expression pattern in SASPA-Test as given in a percentage from before anesthesia
时间窗: 70-90 min
before and following anesthesia period over 60 min
次要结局
- Reduction of phagocytosis activity as a percentage of base line (prior to anesthesia)(70-90 min)
- Protein expression pattern of monocytes by proteomics analysis and mass spectrometry(70-90 min)
研究者
Thomas Frietsch
Associate Professor of the Dept. of Anesthesiology and Critical Care Medicine
Universitätsmedizin Mannheim