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Influence of Propofol on Alveolar Macrophage in Asthmatic Patients

NCT ID: NCT00676416

Last Updated: 2009-03-31

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-03-31

Brief Summary

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The change of airway responsiveness and alveolar macrophage (AM) immunity occurs during the pathogenesis of asthma. Macrophage-associated airway protection in patients with asthma is affected positively or negatively by propofol general anesthesia. The investigators hypothesized that the effects of propofol on asthmatic AMs and corresponding airway reactivity in vivo is different from the in vitro research. Through in vivo airway hyperresponsiveness (AHR) observation and clinical investigation of AM immune functions from asthma patients undergoing propofol general anesthesia to clarify the precise effects of propofol on AM immunity, and to provide theoretical basis for the clinical administration of propofol in asthmatic patients. This would optimize the practice of clinical anesthesia, especially for those with the tendency of AHR.

Detailed Description

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Conditions

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Asthma

Keywords

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General anesthesia Propofol Immunity Alveolar Macrophages

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Propofol general anesthesia for asthmatic patients

2,6-Diisopropylphenol

Intervention Type DRUG

Propofol general anesthesia was performed in patients with asthma (1) and without asthma (2)

2

Propofol general anesthesia for non-asthmatic patients

2,6-Diisopropylphenol

Intervention Type DRUG

Propofol general anesthesia was performed in patients with asthma (1) and without asthma (2)

Interventions

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2,6-Diisopropylphenol

Propofol general anesthesia was performed in patients with asthma (1) and without asthma (2)

Intervention Type DRUG

Other Intervention Names

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Diprivan

Eligibility Criteria

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Inclusion Criteria

* ASA physical status I-II;
* Aged from 18 years to 45 years;
* Patients with or without asthma or a history record of asthma;
* Undergoing elective lumpectomy under general anesthesia.

Exclusion Criteria

* Allergy to propofol and opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records;
* Participants younger than 18yr，older than 45yr or pregnancy;
* Those who were not willing to or could not finish the whole study at any time;
* The PACU assessing score was under 6 on a scale of 10 (measuring somnolence, respiration, movement, color, and blood pressure on 0-2 scales), and arterial oxygen saturation measured by pulse oximetry (SaO2) was 92% or lower (supplemental oxygen was permitted).
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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HRSA/Maternal and Child Health Bureau

FED

Sponsor Role collaborator

Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Nanjing Medical University

Principal Investigators

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XiaoFeng Shen, MD

Role: STUDY_DIRECTOR

Nanjing Medical University

Locations

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Nanjing Maternal and Child Health Care Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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NMU-08-1090

Identifier Type: -

Identifier Source: secondary_id

NMCHCH-0288-323

Identifier Type: -

Identifier Source: org_study_id