Influence of Propofol on Alveolar Macrophage in Asthmatic Patients (PAMAP)

March 30, 2009 updated by: Nanjing Medical University

Influence of Propofol on Alveolar Macrophage Immunity in Asthmatic Patients Undergoing General Anesthesia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210004
        • Nanjing Maternal and Child Health Care Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients with or without asthma undergoing general anesthesia

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Propofol general anesthesia for asthmatic patients
Drug: 2,6-Diisopropylphenol
Propofol general anesthesia was performed in patients with asthma (1) and without asthma (2)
Other Names:
  • Diprivan
2
Propofol general anesthesia for non-asthmatic patients
Drug: 2,6-Diisopropylphenol
Propofol general anesthesia was performed in patients with asthma (1) and without asthma (2)
Other Names:
  • Diprivan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Alveolar macrophage viability assay
Time Frame: One day prior to the surgery, immediately after anaesthesia, at the beginning and the end of the operation and one day after surgeries.
One day prior to the surgery, immediately after anaesthesia, at the beginning and the end of the operation and one day after surgeries.

Secondary Outcome Measures

Outcome Measure
Time Frame
Alveolar macrophage phagocytosis Assay
Time Frame: One day prior to the surgery, immediately after anaesthesia, at the beginning and the end of the operation and one day after surgeries.
One day prior to the surgery, immediately after anaesthesia, at the beginning and the end of the operation and one day after surgeries.
Alveolar macrophage cytokine Assay
Time Frame: One day before the surgery, immediately after anaesthesia, at the beginning and the end of the operation and one day after surgeries.
One day before the surgery, immediately after anaesthesia, at the beginning and the end of the operation and one day after surgeries.
Mean airway pressure
Time Frame: Before operation to the end of the surgery.
Before operation to the end of the surgery.
Curve shape of CO2
Time Frame: Before operation to the end of the surgery.
Before operation to the end of the surgery.
End-tidal CO2
Time Frame: Before operation to the end of the surgery.
Before operation to the end of the surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Medical University

Collaborators

HRSA/Maternal and Child Health Bureau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

May 8, 2008

First Submitted That Met QC Criteria

May 12, 2008

First Posted (Estimate)

May 13, 2008

Study Record Updates

Last Update Posted (Estimate)

March 31, 2009

Last Update Submitted That Met QC Criteria

March 30, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMCHCH-0288-323
  • NMU-08-1090

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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