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

Primary Purpose

Anesthesia, Asthma

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Anesthesia induction
Anesthesia maintenance
Assisted anesthesia
Sponsored by
Second Affiliated Hospital of Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anesthesia focused on measuring Dexmedetomidine, Inflammatory factor, Inflammatory mediator, Cytokines, Asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    non-asthma group

    Dexmedetomidine A

    Dexmedetomidine B

    Control group

    Arm Description

    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.

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    IL-4，IL-5，IL-13, IL-17, IL-33 concentration in the Plasma
    Histamine concentration
    Myelin Basic Protein concentration （MBP)
    IgE concentration

    Secondary Outcome Measures

    Mean arterial pressure（MAP）
    Heart rate（HR）
    Respiratory rate（RR）

    Full Information

    First Posted
    November 10, 2014
    Last Updated
    November 10, 2014
    Sponsor
    Second Affiliated Hospital of Xi'an Jiaotong University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02289391
    Brief Title
    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

    2. Study Status

    Record Verification Date
    November 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2014 (undefined)
    Primary Completion Date
    December 2015 (Anticipated)
    Study Completion Date
    December 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Second Affiliated Hospital of Xi'an Jiaotong University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anesthesia, Asthma
    Keywords
    Dexmedetomidine, Inflammatory factor, Inflammatory mediator, Cytokines, Asthma

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    non-asthma group
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Arm Title
    Dexmedetomidine A
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Dexmedetomidine B
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control group
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Anesthesia induction
    Intervention Description
    -Intravenous injection midazolam 0.05 mg/Kg,fentanyl 4μg/Kg,etomidate 0.2 mg/Kg,cisatracurium 0.15 mg/Kg in proper order.
    Intervention Type
    Drug
    Intervention Name(s)
    Anesthesia maintenance
    Intervention Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Assisted anesthesia
    Intervention Description
    Intervention 'Assisted anesthesia' has been included in Arm Descriptions.
    Primary Outcome Measure Information:
    Title
    IL-4，IL-5，IL-13, IL-17, IL-33 concentration in the Plasma
    Time Frame
    enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
    Title
    Histamine concentration
    Time Frame
    enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
    Title
    Myelin Basic Protein concentration （MBP)
    Time Frame
    enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
    Title
    IgE concentration
    Time Frame
    enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
    Secondary Outcome Measure Information:
    Title
    Mean arterial pressure（MAP）
    Time Frame
    enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
    Title
    Heart rate（HR）
    Time Frame
    enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
    Title
    Respiratory rate（RR）
    Time Frame
    enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    NIU XIAOLI
    Organizational Affiliation
    The second affiliated hospital of xi 'an jiaotong university
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18982161
    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.
    Results Reference
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    PubMed Identifier
    14600429
    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.
    Results Reference
    background
    PubMed Identifier
    11919085
    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.
    Results Reference
    background
    PubMed Identifier
    11435252
    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.
    Results Reference
    background
    PubMed Identifier
    15187514
    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.
    Results Reference
    background
    PubMed Identifier
    12100061
    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.
    Results Reference
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    Effect of Dexmedetomidine on Levels of Plasma Inflammatory Factor in Asthma Patients Undergoing General Anesthesia

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