Effects of Intravenous Lidocaine on Serum THBS2, MMPS and VEGF-C in Patients Undergoing Radical Hyterectomy Surgery After General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Changes from Baseline THBS2 before anaesthetic induction and 48 hours after surgery
研究概览
简要总结
The purpose of this study is to investigate the efficacy of intravenous lidocaine on THBS2, MMPs and VEGF-C in serum in cervical cancer patients undergoing radical hysterectomy under general anesthesia.
详细描述
The surgical stress response to tumour removal causes bloodstream release of a variety of pro-inflammatory cytokines and other molecules which may affect perioperative immune response and other conditions conducive to residual tumour cell survival that could later emerge as clinical recurrences or metastasis. Lidocaine has analgesic and anti-inflammatory effects, and may also have specific anticancer properties.
Blood serum expression of these molecules (metalloproteinases, vascular endothelial growth factor [VEGF], epidermal growth factor）, play a important role in the metastatic process and tumor progression. lidocaine could affect the course and growth of metastatic tumors by changing the cancer cells, the tumor microenvironment, or both.
We tested the hypothesis that women undergoing cervical cancer resection with these techniques (intravenous lidocaine) have reduced postoperative serum expression of metastasis biomarkers, and may change the outcomes of cancer patients.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients were scheduled by following cervical cancer surgery under general anesthesia
- •Aged 18-65 years
- •ASA physical status Ⅱ-Ⅲ
排除标准
- •Severe heart, pulmonary, hepatic and renal insufficiency
- •History of neurological diseases
- •Autoimmune disorders
- •Antiarrhythmic drugs (amiodarone, verapamil, propafenone)
- •Patients' decision to withdraw anytime from the study, and refusal to participate before surgery and at postoperative follow-up
- •Allergy to one of the used medications
- •Psychiatric illness, psychological disorder, and drug or alcohol abuse
- •Unwillingness to comply with the protocol or procedures
- •Preoperative treatment of chemotherapy, radiation, NSAID and hormonal therapy
- •History of anesthesia and surgery in two weeks
- •Coexisting other cancers and intraoperative presence of liver metastasis
- •Perioperative treatment of blood transfusion
研究组 & 干预措施
Lidocaine
Intravenous bolus of 1.5 mg/kg of lidocaine followed by a continuous infusion of 3.0 mg/kg for the first hour, 1.5 mg/kg for the second hour, 0.7 mg/kg for the next 22h.
干预措施: Lidocaine (Drug)
Normal saline
Normal saline administered as a bolus and an infusion with identical volume and rate changes as the treatment group.
干预措施: Normal saline (NS) (Other)
结局指标
主要结局
Changes from Baseline THBS2 before anaesthetic induction and 48 hours after surgery
时间窗: Baseline and 48 hours after operation
Blood samples (5 ml) were drawn from each patient before anaesthetic induction, at the end of the operation, 24h and 48 h after operation
Changes from Baseline MMP-2 before anaesthetic induction and 48 hours after surgery
时间窗: Baseline and 48 hours after operation
Blood samples (5 ml) were drawn from each patient before anaesthetic induction, at the end of the operation, 24h and 48 h after operation
Changes from Baseline MMP-9 before anaesthetic induction and 48 hours after surgery
时间窗: Baseline and 48 hours after operation
Blood samples (5 ml) were drawn from each patient before anaesthetic induction, at the end of the operation, 24h and 48 h after operation
Changes from Baseline VEGF-C before anaesthetic induction and 48 hours after surgery
时间窗: Baseline and 48 hours after operation
Blood samples (5 ml) were drawn from each patient before anaesthetic induction, at the end of the operation, 24h and 48 h after operation
次要结局
- Monitoring the severity of postoperative pain with verbalre sponse pain score during the first 48hours postoperatively(at the end of operation and 48 hours after operation)
- Resumption of bowel function(at the end of operation and 48 hours after operation)