Effects of Anesthetic Technique on Natural Killer Cell Population and Cytotoxicity
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Natural Killer Cell Cytotoxicty
研究概览
简要总结
The proposed study is a pilot prospective, single-blinded, randomized controlled trial evaluating the effects of two routine, standard-of-care, anesthetic techniques on natural killer cell population size and cytotoxicity in patients undergoing exploratory abdominal laparotomies.
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
- Single (Participant)
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
- 是
入选标准
- •18 - 80 years old of either gender
- •Diagnosis of abdominal tumor scheduled for exploratory laparotomy with study surgeon
- •Must be able to have an epidural
排除标准
- •ASA IV and above
- •Intolerance, allergy, or contraindication to use of either fentanyl or bupivacaine.
- •Significant coronary artery disease (abnormal stress test, myocardial infarction within the last 3 months)
- •Uncontrolled hypertension (BP > 140/90)
- •Cardiac arrhythmias particularly prolonged QT syndrome
- •Drugs known to cause prolonged qT: class IA antiarrhythmics (quinidine, procainamide, dysopyramide), class III antiarrhythmics (sotalol, dofetalide, ibutalide, amiodarone), haloperidol, thioridazine, arsenic trioxide, HIV protease inhibitors, tricyclic antidepressants
- •Individuals with significant psychological disorders including: schizophrenia, mania, bipolar disorder or psychosis
- •Pregnant or lactating women
- •Morbid obesity (BMI > 40 kg/m2) AND/OR weight > 150 kg
- •Chronic renal failure ( creatinine > 2.0 mg/dL)
- •Liver failure e.g., active cirrhosis
- •Alcohol or substance abuse within in the past 3 months
- •Uncorrected hypokalemia, hypomagnesemia, hypocalcemia (can be due to diuretics, mineralocorticoid use, laxatives)
- •Neuropathic pain
- •Chronic opioid consumption (>30mg oxycodone or greater per day)
- •Cachexia from any cause
- •Systemic use of corticosteroids for greater than 2 weeks in the 6 months prior to surgery
- •HIV or other immunosuppressive condition
- •Preoperative INR > 1.4 or platelet count < 100
- •Sepsis or overlying skin cellulitis at epidural catheter insertion site
- •Inability to tolerate/unwillingness to have an epidural catheter for intraoperative/postoperative pain control for any reason, including prior back surgery resulting in distorted anatomy that precludes neuraxial anesthesia.
- •Inability to tolerate an epidural solution of either fentanyl or bupivacaine or needs another form of specialized pain control.
研究组 & 干预措施
'Bupivacaine + Fentanyl' (Opioid Group)
Group 1 (opioid group) will receive general endotracheal anesthesia augmented with an epidural. The epidural solution intraoperatively and post-operatively will contain fentanyl + bupivacaine titrated to appropriate surgical conditions and post-operative pain control.
干预措施: Bupivacaine + Fentanyl (Drug)
Bupivacaine (Local Anesthetic Group)
Group 2 (local anesthetic group) will receive general endotracheal anesthesia augmented with an epidural. The epidural solution intraoperatively and post-operatively will contain bupivacaine titrated to appropriate surgical conditions and post-operative pain control.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Natural Killer Cell Cytotoxicty
时间窗: One Year
Cytotoxicity will be assessed using Flow Cytometric analysis of cell receptor expression.
次要结局
未报告次要终点
研究者
Roya Yumul, M.D.,PhD.
Program Director, Anesthesiology
Cedars-Sinai Medical Center