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临床试验/NCT04771637
NCT04771637已完成不适用

Effect of Dexmedetomidine on Perioperative Internal Environment and Rehabilitation of Patients Undergoing Gastrointestinal Malignant Tumor Resection

Yangzhou University1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2017年1月1日最近更新:
适应症
干预措施
相关药物

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

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

Placebo Comparator

干预措施: Normal saline (Drug)

dexmedetomidine loading dose 1 µg/kg + maintenance dose 0.25 µg/kg/h

Experimental

干预措施: Dexmedetomidine (Drug)

dexmedetomidine loading dose 0.5 µg/kg + maintenance dose 0.5 µg/kg/h

Experimental

干预措施: Dexmedetomidine (Drug)

dexmedetomidine loading dose 1 µg/kg + maintenance dose 0.5 µg/kg/h

Experimental

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

发起方
Yangzhou University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhuan Zhang

Principal Investigator

Yangzhou University

研究点 (1)

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