Effect of Dexmedetomidine Infusion, Lidocaine Infusion, and Intrathecal Morphine Injection on Biomarker for Perioperative Stress and Immune Response, and Cancer Progression and Metastasis in Colorectal Cancer Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- MMP-9
研究概览
简要总结
This is a prospective randomized controlled trial. Investigators aimed to compare the effect of three different anesthetic adjuvants (continuous infusion of lidocaine or dexmedetomidine, intrathecal morphine injection) on the biomarker for cancer recurrence and metastasis.
Patients undergoing elective colorectal cancer surgery will be randomly allocated to three parallel arms and the biomarkers for cancer recurrence and metastasis, inflammation, and immune response will be compared. And we will compare the clinical outcomes in the three method.
详细描述
Perioperative period is critical in determining the risk of postoperative metastatic disease. Surgical damage and related stress response could suppress cell-mediated immunity and facilitate malignant cell survival, motility, invasion and proliferation. Increasing evidence supported that the continuous infusion of lidocaine or dexmedetomidine, or intrathecal morphine were associated with the reduction of postoperative pain and opioid consumption and improved the quality of recovery.
Also, they were reported to decrease perioperative inflammatory responses and preserve immune response which is known to be critical in anti-metastatic process during perioperative period. However, no comparison was conducted among these anesthetic adjuvants. Thus, Investigators try to evaluate the effect on the biomarkers and clinical outcomes in the three methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who were scheduled for elective colorectal cancer surgery American Society of Anesthesiologists physical status of I-III
排除标准
- •Atrioventricular conduction disorder
- •Having Bradycardia (<50 bpm)
- •Severe pulmonary dysfunction in pulmonary function test
- •High risk for cardiovascular complications(expected postoperative event >5%)
- •Allergy or hypersensitivity reaction to each adjuvant.
- •History or risk factors for Malignant hyperthermia
- •Body mass index >40 kg/m2
研究组 & 干预措施
Lidocaine group
A loading dose of 1.5mg/kg lidocaine will be infused for 10 minutes during anesthesia induction. During the surgery and post-anaesthesia care unit (PACU) stay, 1.5 mg/kg/h of lidocaine were continuously infused until the patient was transferred to the general ward.
干预措施: Lidocaine IV (Drug)
Dexmedetomidine group
A loading dose of 0.3mcg/kg dexmedetomidine will be infused for 10 minutes during anesthesia induction. During the surgery and PACU stay, 0.3 mcg/kg/h of dexmedetomidine were continuously infused until the patient was transferred to the general ward.
干预措施: Dexmedetomidine IV (Drug)
Intrathecal Morphine group
200~300mcg of Intrathecal morphine will be injected at the anesthesia induction for colorectal surgery.
干预措施: intrathecal morphine (Drug)
结局指标
主要结局
MMP-9
时间窗: 1 hour after surgery
plasma Matrix metalloproteinase-9
次要结局
- MMP-9(at the induction of anesthesia)
- MMP-2(at the inudction of anesthesia, 1 hour after surgery, 1 day after surgery)
- IL-6(at the inudction of anesthesia, 1 hour after surgery, 1 day after surgery)
- VEGF(at the inudction of anesthesia, 1 hour after surgery, 1 day after surgery)
- lymphocyte subset(at the inudction of anesthesia, 1 hour after surgery, 1 day after surgery)
- numeric rating scale(within 3 days after the surgery (1, 6, 24, 48, 72 hour after surgery))
- Opioid consumption(within 3 days after the surgery (1, 6, 24, 48, 72 hour after surgery))
- postoperative nausea/vomiting(within 3 days after the surgery (1, 6, 24, 48, 72 hour after surgery))
- Time to flatus(within 7 days after the surgery)
- Hospital length of stay(Until the discharge (up to postoperative day 30))
- respiratory depression(during the night of surgery)
- urinary retention(within 7 days after the surgery)
- Headache and itching sensation(within 3 and 1 day after surgery, respectively)
- reoperation and readmission rate(within 1 month after surgery and discharge, respectively)
研究者
MiHye Park
assistant professor
Samsung Medical Center