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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02289391
• Other study ID #: Dexmedetomidine-14115
• Status: Not yet recruiting
• Phase: Phase 4
• First received: November 10, 2014
• Last updated: November 10, 2014
• Start date: December 2014
• Est. completion date: December 2015

Study information

• Verified date: November 2014
• Source: Second Affiliated Hospital of Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anesthesia
• Asthma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Xi'an Jiaotong University

References & Publications (6)

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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	Histamine concentration		enter the operation room(T0)?10min after intubation(T1)? skin incision(T2)?the end of surgery(T3)?24H after surgery(T4)	No
Primary	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)	No
Primary	IgE concentration		enter the operation room(T0)?10min after intubation(T1)? skin incision(T2)?the end of surgery(T3)?24H after surgery(T4)	No
Secondary	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)	Yes
Secondary	Heart rate(HR)		enter the operation room(T0)?10min after intubation(T1)? skin incision(T2)?the end of surgery(T3)?24H after surgery(T4)	Yes
Secondary	Respiratory rate(RR)		enter the operation room(T0)?10min after intubation(T1)? skin incision(T2)?the end of surgery(T3)?24H after surgery(T4)	Yes