Effect of Dexmedetomidine on Levels of Plasma Inflammatory Factor in Asthma Patients Undergoing General Anesthesia

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Dexmedetomidine on Levels of Plasma Inflammatory Factor in Asthma Patients Undergoing General Anesthesia-single Center,Randomized,Double-blind，Controlled Trial

Conditions
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Asthma, Anesthesia

Intervention / Treatment
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* Drug: Anesthesia induction
* Drug: Anesthesia maintenance
* Drug: Assisted anesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: non-asthma group<br>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. | Drug: Anesthesia induction<br>* -Intravenous injection midazolam 0.05 mg/Kg,fentanyl 4μg/Kg,etomidate 0.2 mg/Kg,cisatracurium 0.15 mg/Kg in proper order.<br>Drug: Anesthesia maintenance<br>* Continuous intravenous remifentanil O.2μg/(kg•h) and propofol 3 8mg/(kg•h). Intermittent intravenous atracurium 0.05mg/kg. Maintain partial pressure of carbon dioxide(PETCO2) to 30 40 mmHg and bispectral index (BIS) to 45 60.<br>|
| Experimental: Dexmedetomidine A<br>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. | Drug: Anesthesia induction<br>* -Intravenous injection midazolam 0.05 mg/Kg,fentanyl 4μg/Kg,etomidate 0.2 mg/Kg,cisatracurium 0.15 mg/Kg in proper order.<br>Drug: Anesthesia maintenance<br>* Continuous intravenous remifentanil O.2μg/(kg•h) and propofol 3 8mg/(kg•h). Intermittent intravenous atracurium 0.05mg/kg. Maintain partial pressure of carbon dioxide(PETCO2) to 30 40 mmHg and bispectral index (BIS) to 45 60.<br>Drug: Assisted anesthesia<br>* Intervention 'Assisted anesthesia' has been included in Arm Descriptions.<br>|
| Experimental: Dexmedetomidine B<br>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. | Drug: Anesthesia induction<br>* -Intravenous injection midazolam 0.05 mg/Kg,fentanyl 4μg/Kg,etomidate 0.2 mg/Kg,cisatracurium 0.15 mg/Kg in proper order.<br>Drug: Anesthesia maintenance<br>* Continuous intravenous remifentanil O.2μg/(kg•h) and propofol 3 8mg/(kg•h). Intermittent intravenous atracurium 0.05mg/kg. Maintain partial pressure of carbon dioxide(PETCO2) to 30 40 mmHg and bispectral index (BIS) to 45 60.<br>Drug: Assisted anesthesia<br>* Intervention 'Assisted anesthesia' has been included in Arm Descriptions.<br>|
| Placebo Comparator: Control group<br>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. | Drug: Anesthesia induction<br>* -Intravenous injection midazolam 0.05 mg/Kg,fentanyl 4μg/Kg,etomidate 0.2 mg/Kg,cisatracurium 0.15 mg/Kg in proper order.<br>Drug: Anesthesia maintenance<br>* Continuous intravenous remifentanil O.2μg/(kg•h) and propofol 3 8mg/(kg•h). Intermittent intravenous atracurium 0.05mg/kg. Maintain partial pressure of carbon dioxide(PETCO2) to 30 40 mmHg and bispectral index (BIS) to 45 60.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IL-4，IL-5，IL-13, IL-17, IL-33 concentration in the Plasma |  | enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4) | 
| Histamine concentration |  | 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) |  | enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4) | 
| IgE concentration |  | enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine, Inflammatory factor, Inflammatory mediator, Cytokines, Asthma