NCT02289391Unknown4 期
Effect of Dexmedetomidine on Levels of Plasma Inflammatory Factor in Asthma Patients Undergoing General Anesthesia-single Center,Randomized,Double-blind，Controlled Trial
Second Affiliated Hospital of Xi'an Jiaotong University0 个研究点目标入组 80 人开始时间: 2014年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 主要终点
- IgE concentration
研究概览
简要总结
The study try to illustrate the possible mechanisms of tending to induce airway spasms and the impact of dexmedetomidine on inflammatory reaction in general anesthesia patients with asthma，by detecting the differences of plasma inflammatory factor interleukin(IL)-4, IL-5, IL-13, IL-17, IL-33, MBP and immunoglobulin E(IgE) levels between asthma patients and non-asthma 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, Investigator)
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
- •Obtain informed consent
- •Elective general anesthesia surgery, surgery time 1 ~ 3 hours.
- •20 patients with a history of asthma.
- •60 patients with no history of asthma.
- •American Society of Anesthesiologists (ASA)classification:class I~II.
- •Aged between 18 and 65 years old.
排除标准
- •SBP≥180 mmHg or <90 mmHg, DBP≥110 mmHg or <60 mmHg.
- •Serious heart, brain, liver, kidney, lung, endocrine diseases or serious infections.
- •Hematopoietic dysfunction or bleeding tendency and hemorrhagic disease.
- •A neuromuscular system disease.
- •Airway and lung surgery.
- •Predict possible or happened difficult airway.
- •Immune function defect.
- •Sure/suspected abuse of narcotic analgesics or drugs or alcohol dependence.
- •The test drug allergy or have other contraindications in patients.
- •Childbearing age women not to take appropriate contraception, pregnancy or lactation.
- •Participated in other clinical drug research in the last 30 days.
研究组 & 干预措施
non-asthma group
Placebo Comparator
- Non-asthma history
- Infusion of normal saline(1μg/kg) at 10 minutes before anesthesia induction.
- Infusion of normal saline at 0.4μg•kg-1•h-1during anesthesia maintenance.
- Stop infusion of normal saline at 10 minutes before the end of surgery.
干预措施: Anesthesia induction (Drug)
non-asthma group
Placebo Comparator
- Non-asthma history
- Infusion of normal saline(1μg/kg) at 10 minutes before anesthesia induction.
- Infusion of normal saline at 0.4μg•kg-1•h-1during anesthesia maintenance.
- Stop infusion of normal saline at 10 minutes before the end of surgery.
干预措施: Anesthesia maintenance (Drug)
Dexmedetomidine A
Experimental
- With a history of asthma
- Infusion of dexmedetomidine(1μg/kg) at 10 minutes before anesthesia induction.
- Infusion of dexmedetomidine at 0.4μg•kg-1•h-1during anesthesia maintenance.
- Stop infusion of dexmedetomidine at 10 minutes before the end of surgery.
干预措施: Anesthesia induction (Drug)
Dexmedetomidine A
Experimental
- With a history of asthma
- Infusion of dexmedetomidine(1μg/kg) at 10 minutes before anesthesia induction.
- Infusion of dexmedetomidine at 0.4μg•kg-1•h-1during anesthesia maintenance.
- Stop infusion of dexmedetomidine at 10 minutes before the end of surgery.
干预措施: Anesthesia maintenance (Drug)
Dexmedetomidine A
Experimental
- With a history of asthma
- Infusion of dexmedetomidine(1μg/kg) at 10 minutes before anesthesia induction.
- Infusion of dexmedetomidine at 0.4μg•kg-1•h-1during anesthesia maintenance.
- Stop infusion of dexmedetomidine at 10 minutes before the end of surgery.
干预措施: Assisted anesthesia (Drug)
Dexmedetomidine B
Experimental
- With a history of asthma
- Infusion of dexmedetomidine(1μg/kg) at 10 minutes before anesthesia induction.
- Infusion of dexmedetomidine at 0.7μg•kg-1•h-1during anesthesia maintenance.
- Stop infusion of dexmedetomidine at 10 minutes before the end of surgery.
干预措施: Anesthesia induction (Drug)
Dexmedetomidine B
Experimental
- With a history of asthma
- Infusion of dexmedetomidine(1μg/kg) at 10 minutes before anesthesia induction.
- Infusion of dexmedetomidine at 0.7μg•kg-1•h-1during anesthesia maintenance.
- Stop infusion of dexmedetomidine at 10 minutes before the end of surgery.
干预措施: Anesthesia maintenance (Drug)
Dexmedetomidine B
Experimental
- With a history of asthma
- Infusion of dexmedetomidine(1μg/kg) at 10 minutes before anesthesia induction.
- Infusion of dexmedetomidine at 0.7μg•kg-1•h-1during anesthesia maintenance.
- Stop infusion of dexmedetomidine at 10 minutes before the end of surgery.
干预措施: Assisted anesthesia (Drug)
Control group
Placebo Comparator
- With a history of asthma
- Infusion of normal saline(1μg/kg) at 10 minutes before anesthesia induction.
- Infusion of normal saline at 0.4μg•kg-1•h-1during anesthesia maintenance.
- Stop infusion of normal saline at 10 minutes before the end of surgery.
干预措施: Anesthesia induction (Drug)
Control group
Placebo Comparator
- With a history of asthma
- Infusion of normal saline(1μg/kg) at 10 minutes before anesthesia induction.
- Infusion of normal saline at 0.4μg•kg-1•h-1during anesthesia maintenance.
- Stop infusion of normal saline at 10 minutes before the end of surgery.
干预措施: Anesthesia maintenance (Drug)
结局指标
主要结局
IgE concentration
时间窗: enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
IL-4，IL-5，IL-13, IL-17, IL-33 concentration in the Plasma
时间窗: enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
Histamine concentration
时间窗: enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
Myelin Basic Protein concentration （MBP)
时间窗: enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
次要结局
- Mean arterial pressure（MAP）(enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4))
- Heart rate（HR）(enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4))
- Respiratory rate（RR）(enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4))
研究者
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