The Influence of Perioperative Administration of Dexmedetomidine on Inflammation Response and Postoperative Recovery in Patients Undergoing Robot or Laparoscopic Assisted Gastrectomy; Double Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- CRP level in blood
研究概览
简要总结
Many studies have shown that inflammation has an important effect on the development, progression, and also response to treatment of tumors. Dexmedetomidine is a potent and selective alpha 2 receptor agonist, known to have a sedative, analgesic and immune-controlling effect. The purpose of this study is to investigate the effect of dexmedetomidine during surgery on postoperative inflammatory response and surgical recovery in gastric cancer patients undergoing robot or laparoscopic gastrectomy.
详细描述
- Experimental group (Dexmedetomidine group) Continuous IV Precedex™ using infusion pump (Terufusion TE-311, Terumo, Tokyo, Japan) during surgery (from immediately after induction to before starting peritoneum closure) Infusion rate 0.4μg/kg/hr
- Control group (normal saline group) Continuous IV normal saline using infusion pump (Terufusion TE-311, Terumo, Tokyo, Japan) during surgery Infusion rate 0.4μg/kg/hr
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Investigator prepared the drug and participant and outcomes assessor were blind to the group allocation
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20-70 yrs old patients
- •Scheduled for robot or laparoscopic gastrectomy
- •Body weight under 90kg and BMI under 32
排除标准
- •Emergency operation
- •Reoperation
- •Co-operation with other surgery department
- •Co-operation with other organs (except cholecystectomy)
- •Patients with history of heart failure (unstable angina, congestive heart failure)
- •Patients with history of arrhythmia (specially AV nodal block), ventricular conduction problem
- •Patients with history of uncontrolled hypertension (diastolic BP >110mmHg), extremely bradycardia (HR <45 bpm on ECG)
- •Patients with history of cerebrovascular disease (cerebral hemorrhage, cerebral ischemia
- •Patients who is steroid user
- •Patients who is beta blocker user
- •Patients with history of liver failure, renal failure, allergic to medicine
- •Patients with history of uncontrolled psychiatric disease (PTSD, anxiety, depression)
- •Patients who cannot read the consent form (examples: Illiterate, foreigner)
- •Patients who withdraw the consent
研究组 & 干预措施
Group B (saline)
normal saline infusion group
干预措施: saline (Drug)
Group A (dexmedetomidine)
dexmedetomidine infusion group
干预措施: dexmedetomidine (Drug)
结局指标
主要结局
CRP level in blood
时间窗: first visit after surgery (POD 1 month)
To evaluate the effect of dexmedetomidine on the level of CRP in patients undergoing robot or laparoscopic gastrectomy, CRP level was measured 5 times above time points.
次要结局
- cytokine (IFN-r, TNF-a, IL-6, IL-8, IL-10, HMGB1) level(first visit after surgery (POD 1 month))
- WBC level(first visit after surgery (POD 1 month))
- postoperative pain score (NRS 0~10)(24~48 hours)
- postoperative any unwanted admission(postoperative 1 month)
- gas passing out time(gas passing time immediately after surgery)
- HOD (hospital days)(total days from operation to discharge up to 2 weeks)