Effect of Dexmedetomidine on Perioperative Internal Environment and Rehabilitation of Patients Undergoing Gastrointestinal Malignant Tumor Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- weight
研究概览
简要总结
Dexmedetomidine is a highly selective alpha2-adrenergic receptor agonist with sedative, analgesic, anti-anxiety, and inhibitory sympathetic nerve excitation properties. It is commonly used in clinical anesthesia and intensive care.Radical gastrectomy for gastrointestinal malignant tumors is a common major operation in clinical practice, with long operation time, great trauma and strong stress response of patients. Dexmedetomidine is often used in general anesthesia during such operations, but its long-term use or large dose may produce certain side effects.Common side effects of dexmedetomidine include bradycardia and hypotension, etc. Previous studies have reported that dexmedetomidine can prolong QT interval and is at risk of causing tip torsion type ventricular tachycardia.Abnormal Potassium may affect myocardial repolarization and increase the risk of tip torsion ventricular tachycardia.The main purpose of this study was to observe the effects of long-term use of dexmedetomidine on perioperative internal environment such as electrolyte and rehabilitation indicators during radical general anesthesia for gastrointestinal malignancy, and the secondary purpose was to explore the optimal dose of dexmedetomidine for general anesthesia for patients undergoing radical general anesthesia for gastrointestinal malignancy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I or II;
- •age between 50-75 years, and a body mass index (BMI) between 18.5-28 kg/m2.
排除标准
- •Patients whoused hormones or drugs that have a hypoglycemic nature during the preoperative state, or had bradycardia, arrhythmia, hypotension, abnormal liver or kidney function, pancreatic disease, neuroendocrine malignancy, intraoperative blood transfusion;
- •Patients who refused participation and those who needed intensive care after the surgery were also excluded from the study;
- •Patients who had severe internal environmental disorders.
研究组 & 干预措施
control with normal saline
干预措施: Normal saline (Drug)
dexmedetomidine loading dose 1 µg/kg + maintenance dose 0.25 µg/kg/h
干预措施: Dexmedetomidine (Drug)
dexmedetomidine loading dose 0.5 µg/kg + maintenance dose 0.5 µg/kg/h
干预措施: Dexmedetomidine (Drug)
dexmedetomidine loading dose 1 µg/kg + maintenance dose 0.5 µg/kg/h
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
weight
时间窗: perioperative
weight(kg)
height
时间窗: perioperative
height(m)
sex
时间窗: perioperative
sex(male/female)
age
时间窗: perioperative
the age(years)
ASA status
时间窗: perioperative
ASA status of patients
次要结局
- internal environment(Day 1)
研究者
Zhuan Zhang
Principal Investigator
Yangzhou University
