Effect of Total Intravenous Anesthesia Versus Anesthesia With Volatile Agents on Inflammatory Markers Following Elective Craniotomy for Primary Brain Tumor
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- To study inflammatory changes associated with these two different anesthetic techniques
研究概览
简要总结
If the anesthetic regimen can influence the serum level of inflammatory cytokines and if the levels of cytokines are related to the incidence of post operative complications, these complications may be a function of the anesthetic method. In an effort to find the best anesthetic regimen for patients undergoing craniotomy for intracranial tumors, the researchers will compare the effect of volatile anesthetic with that of total intravenous anesthesia (TIVA) on cytokine levels. The researchers will also compare the composite incidence of some common major post-operative complications after craniotomy for intracranial malignancy.
详细描述
This is a randomized blinded clinical trial. Patients will be randomized into one of two groups. One group will receive a volatile anesthetic (sevoflurane)while the other group will receive intravenous anesthetics (propofol + remifentanil) for maintenance of General Anesthesia.
The anesthesia team will know the result of randomization at induction. Postoperative data will be gathered by research personnel who will be blinded to the anesthetic method used. Patients will be blinded to the anesthetic they receive until after the 4-week outcomes are collected, when they will have the option to be unblinded.
Peripheral blood samples will be taken a total of 7 times; pre-induction to anesthesia, 15 minutes after surgical positioning, after the tumor is extracted, and at 6,12,18, and 24 hours after emergence from anesthesia.
Patients will be called for follow up every week for 4 weeks following discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing general anesthesia for elective surgical excision of a primary brain tumor
- •Age: Older than 18
- •New and recurrent cases will be included
排除标准
- •Patient refusal
- •Emergency craniotomy
- •Craniotomy after head injuries or intracranial bleeding
- •Patients with active inflammatory processes such as infection or immunologic illnesses known to increase baseline immunologic markers
- •Preoperative diagnosis of DVT by lower extremity ultrasound or symptoms
- •Preoperative pulmonary infiltrative disease (pulmonary fibrosis, sarcoid, etc.)
- •Pregnancy
研究组 & 干预措施
Total Intravenous anesthetic
Intravenous anesthetics (propofol + remifentanil) for maintenance of General Anesthesia
干预措施: Propofol + Remifentanil (Drug)
Volatile Anesthetic
Inhalational anesthetics (sevoflurane+remifentanil) for maintenance of General Anesthesia. Patients receive Sevoflurane as a volatile anesthetic and remifentanil as an IV agent for maintenance of general anesthesia.
干预措施: Sevoflurane + Remifentanil (Drug)
结局指标
主要结局
To study inflammatory changes associated with these two different anesthetic techniques
时间窗: 24 hours post-operatively
次要结局
- Because of the linkage between cytokines, thrombotic disease, tissue inflammation and brain edema, we plan to monitor a composite outcome derived from occurrence of DVT, PE, new neurologic deficit, postoperative infection and respiratory failure(4 weeks after discharge)