Effects of Propofol-dexmedetomidine on Immune Function During Total Laryngectomy Surgery Compared With Isoflurane Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- CD3 plasma level
研究概览
简要总结
The aim of this prospective, randomized clinical study is to compare between propofol and isoflurane on perioperative immune cell populations and function in patients undergoing total laryngectomy surgery.
详细描述
The perioperative period might be a critical time in primary cancer surgery because many factors can affect whether recurrence, or metastasis , or elimination by the immune system.
Cancer surgery can induce an acute inflammatory response, due to local tissue damage and the shedding of malignant cells into the blood and lymphocytic circulation although meticulous surgical manipulation. Many evidences suggest that several factors during the perioperative period can affect the immune system.
These could be attributed to the surgery per se, pain, anxiety, hypothermia, blood transfusion, anesthetic technique, and anesthetic drugs .Impairment in the immune system may allow malignant cells to escape immuno-surveillance and metastasize in the perioperative period.As well as increase the risk of postoperative complications, such as systemic inflammatory response syndrome, sepsis, and multi-organ failure.
Previous retrospective clinical studies of both breast and prostate cancer surgery have suggested an association between anaesthetic technique and cancer recurrence.
However ,other retrospective trials on various forms of cancer have shown no such benefit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical status I- III
- •Scheduled for total laryngectomy.
排除标准
- •Patients refusal.
- •Morbid obese patients (body mass index >40 kg/m2).
- •Allergy to local anesthetics agents used.
- •Severely altered consciousness level.
- •Psychiatric disorders.
- •Severe or uncompensated cardiovascular disease.
- •Severe renal disease.
- •Severe hepatic disease.
- •Severe endocrinal diseases.
研究组 & 干预措施
Propofol group
Patients receive only intravenous anesthetics
干预措施: Propofol group (Drug)
Isoflurane group
Patients receive isoflurane /fentanyl anesthesia
干预措施: Isoflurane group (Drug)
结局指标
主要结局
CD3 plasma level
时间窗: for 7 days after procedure
Venous blood samples will be collected. The extracted venous blood samples will be mixed evenly in a special anti-coagulation test tube and stored in a refrigerator (at 4C).Flow cytometer will be used to detect the level of CD3+
次要结局
- Heart rate(for 5 hours during the procedure)
- Blood pressure(for 5 hours during the procedure)
- Peripheral oxygen saturation measured with pulse oximetry(for 5 hours during the procedure)