The Influence of Perioperative Administration of Dexmedetomidine on Inflammation Response and Postoperative Outcomes in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Cytoreductive Surgery; Double Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- IL-6 level
研究概览
简要总结
Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) has been reported to be an effective treatment approach for peritoneal cancer, however, the stress response to HIPEC is major neuroendocrine and cytokine response, which has been considered as the homeostatic defense mechanism. Recently, dexmedetomidine has been suggested to exhibit anti-inflammatory properties. This study was designed to evaluate the effect of perioperative administration of dexmedetomidine on inflammation response and postoperative outcomes in patients undergoing hyperthermic intraperitoneal chemotherapy (HIPEC) cytoreductive surgery.
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
- •patients between 20 and 70 years old
- •obtaining written informed consent from the patients who were undergoing hyperthermic intraperitoneal chemotherapy (HIPEC) cytoreductive surgery
- •weights under 90 kg and BMI under 32
排除标准
- •emergency operation
- •re-operations
- •combined surgery over 4 departments.
- •cardiac disease (unstable angina, congestive heart failure, valvular heart disease)
- •Ventricular conduction abnormality
- •prior pacemaker insertion
- •uncontrolled hypertension (diastolic blood pressure > 110mmHg)
- •bradycardia (HR < 40 Bpm)
- •cerebral vascular disease (cerebral hemorrhage, cerebral ischemia)
- •hepatic or renal failure
- •patients who take antiarrythmic agent
- •neurological or psychiatric illnesses
- •foreigner and patient who can not read the letter
研究组 & 干预措施
dexmedetomidine infusion group
干预措施: dexmedetomidine (Drug)
normal saline infusion group
干预措施: Normal saline (Drug)
结局指标
主要结局
IL-6 level
时间窗: Up to 12 hours after surgery
To evaluate the effect of dexmedetomidine on the level of IL-6 in patient undergoing HIPEC, IL-6 level was measured up to 12 hours after surgery.
次要结局
- recurrence rate(up to 1 year after surgery)