Clinical trial NCT02289391: Effect of Dexmedetomidine on Levels of Plasma Inflammatory Factor in Asthma Patients Undergoing General Anesthesia
Official title: Effect of Dexmedetomidine on Levels of Plasma Inflammatory Factor in Asthma Patients Undergoing General Anesthesia-single Center,Randomized,Double-blind，Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthesia
Asthma
Keywords: Dexmedetomidine
Inflammatory factor
Inflammatory mediator
Cytokines
Asthma
Lead sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2014-11-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: IL-4，IL-5，IL-13, IL-17, IL-33 concentration in the Plasma
timeFrame: enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
measure: Histamine concentration
timeFrame: enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
measure: Myelin Basic Protein concentration （MBP)
timeFrame: enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
measure: IgE concentration
timeFrame: enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
Secondary outcomes:
measure: Mean arterial pressure（MAP）
timeFrame: enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
measure: Heart rate（HR）
timeFrame: enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
measure: Respiratory rate（RR）
timeFrame: enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
Other outcomes:
Locations:
Study officials:
affiliation: The second affiliated hospital of xi 'an jiaotong university
name: NIU XIAOLI
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barnes PJ. The cytokine network in asthma and chronic obstructive pulmonary disease. J Clin Invest. 2008 Nov;118(11):3546-56. doi: 10.1172/JCI36130.
citation: Saito A, Okazaki H, Sugawara I, Yamamoto K, Takizawa H. Potential action of IL-4 and IL-13 as fibrogenic factors on lung fibroblasts in vitro. Int Arch Allergy Immunol. 2003 Oct;132(2):168-76. doi: 10.1159/000073718.
citation: Wen FQ, Kohyama T, Liu X, Zhu YK, Wang H, Kim HJ, Kobayashi T, Abe S, Spurzem JR, Rennard SI. Interleukin-4- and interleukin-13-enhanced transforming growth factor-beta2 production in cultured human bronchial epithelial cells is attenuated by interferon-gamma. Am J Respir Cell Mol Biol. 2002 Apr;26(4):484-90. doi: 10.1165/ajrcmb.26.4.4784.
citation: Laporte JC, Moore PE, Baraldo S, Jouvin MH, Church TL, Schwartzman IN, Panettieri RA Jr, Kinet JP, Shore SA. Direct effects of interleukin-13 on signaling pathways for physiological responses in cultured human airway smooth muscle cells. Am J Respir Crit Care Med. 2001 Jul 1;164(1):141-8. doi: 10.1164/ajrccm.164.1.2008060.
citation: Taniguchi T, Kidani Y, Kanakura H, Takemoto Y, Yamamoto K. Effects of dexmedetomidine on mortality rate and inflammatory responses to endotoxin-induced shock in rats. Crit Care Med. 2004 Jun;32(6):1322-6. doi: 10.1097/01.ccm.0000128579.84228.2a.
citation: Kumar RK, Herbert C, Yang M, Koskinen AM, McKenzie AN, Foster PS. Role of interleukin-13 in eosinophil accumulation and airway remodelling in a mouse model of chronic asthma. Clin Exp Allergy. 2002 Jul;32(7):1104-11. doi: 10.1046/j.1365-2222.2002.01420.x.