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

NCT02289391 | Unknown Phase 4

• 1 other identifier: Dexmedetomidine-14115
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia; Asthma

Keywords

Dexmedetomidine; Inflammatory factor; Inflammatory mediator; Cytokines; Asthma

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• 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)

Study Arms (4)

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.

Drug: Anesthesia induction; Drug: Anesthesia maintenance

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.

Drug: Anesthesia induction; Drug: Anesthesia maintenance; Drug: Assisted anesthesia

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.

Drug: Anesthesia induction; Drug: Anesthesia maintenance; Drug: Assisted anesthesia

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.

Drug: Anesthesia induction; Drug: Anesthesia maintenance

Interventions

Anesthesia induction DRUG

-Intravenous injection midazolam 0.05 mg/Kg,fentanyl 4μg/Kg,etomidate 0.2 mg/Kg,cisatracurium 0.15 mg/Kg in proper order.

Control group; Dexmedetomidine A; Dexmedetomidine B; non-asthma group

Anesthesia maintenance DRUG

* 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.

Control group; Dexmedetomidine A; Dexmedetomidine B; non-asthma group

Assisted anesthesia DRUG

Intervention 'Assisted anesthesia' has been included in Arm Descriptions.

Dexmedetomidine A; Dexmedetomidine B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obtain informed consent
• Elective general anesthesia surgery, surgery time 1 \~ 3 hours.
• patients with a history of asthma.
• patients with no history of asthma.
• American Society of Anesthesiologists (ASA)classification:class I\~II.
• Aged between 18 and 65 years old.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead

Related 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.

  PMID: 18982161 BACKGROUND

• 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.

  PMID: 14600429 BACKGROUND

• 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.

  PMID: 11919085 BACKGROUND

• 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.

  PMID: 11435252 BACKGROUND

• 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.

  PMID: 15187514 BACKGROUND

• 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.

  PMID: 12100061 BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• NIU XIAOLI

  The second affiliated hospital of xi 'an jiaotong university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2014
• First Posted: November 13, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 13, 2014

Record last verified: 2014-11