Effect of Dexmedetomidine on Levels of Plasma Inflammatory Factor in Asthma Patients Undergoing General Anesthesia
NCT ID: NCT02289391
Last Updated: 2014-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
80 participants
INTERVENTIONAL
2014-12-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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non-asthma group
* 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.
Anesthesia induction
-Intravenous injection midazolam 0.05 mg/Kg,fentanyl 4μg/Kg,etomidate 0.2 mg/Kg,cisatracurium 0.15 mg/Kg in proper order.
Anesthesia maintenance
* 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.
Dexmedetomidine A
* 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.
Anesthesia induction
-Intravenous injection midazolam 0.05 mg/Kg,fentanyl 4μg/Kg,etomidate 0.2 mg/Kg,cisatracurium 0.15 mg/Kg in proper order.
Anesthesia maintenance
* 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.
Assisted anesthesia
Intervention 'Assisted anesthesia' has been included in Arm Descriptions.
Dexmedetomidine B
* 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.
Anesthesia induction
-Intravenous injection midazolam 0.05 mg/Kg,fentanyl 4μg/Kg,etomidate 0.2 mg/Kg,cisatracurium 0.15 mg/Kg in proper order.
Anesthesia maintenance
* 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.
Assisted anesthesia
Intervention 'Assisted anesthesia' has been included in Arm Descriptions.
Control group
* 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.
Anesthesia induction
-Intravenous injection midazolam 0.05 mg/Kg,fentanyl 4μg/Kg,etomidate 0.2 mg/Kg,cisatracurium 0.15 mg/Kg in proper order.
Anesthesia maintenance
* 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.
Interventions
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Anesthesia induction
-Intravenous injection midazolam 0.05 mg/Kg,fentanyl 4μg/Kg,etomidate 0.2 mg/Kg,cisatracurium 0.15 mg/Kg in proper order.
Anesthesia maintenance
* 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.
Assisted anesthesia
Intervention 'Assisted anesthesia' has been included in Arm Descriptions.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Second Affiliated Hospital of Xi'an Jiaotong University
OTHER
Responsible Party
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Principal Investigators
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NIU XIAOLI
Role: PRINCIPAL_INVESTIGATOR
The second affiliated hospital of xi 'an jiaotong university
References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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Dexmedetomidine-14115
Identifier Type: -
Identifier Source: org_study_id