NCT00676416

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 8, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 13, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

March 31, 2009

Status Verified

March 1, 2009

Enrollment Period

11 months

First QC Date

May 8, 2008

Last Update Submit

March 30, 2009

Conditions

Asthma

Keywords

General anesthesiaPropofolImmunityAlveolar Macrophages

Outcome Measures

Primary Outcomes (1)

  • Alveolar macrophage viability assay

    One day prior to the surgery, immediately after anaesthesia, at the beginning and the end of the operation and one day after surgeries.

Secondary Outcomes (5)

  • Alveolar macrophage phagocytosis Assay

    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

    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

    Before operation to the end of the surgery.

  • Curve shape of CO2

    Before operation to the end of the surgery.

  • End-tidal CO2

    Before operation to the end of the surgery.

Study Arms (2)

1

Propofol general anesthesia for asthmatic patients

Drug: 2,6-Diisopropylphenol

2

Propofol general anesthesia for non-asthmatic patients

Drug: 2,6-Diisopropylphenol

Interventions

2,6-DiisopropylphenolDRUG

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

Also known as: Diprivan
12

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with or without asthma undergoing general anesthesia

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Maternal and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Location

MeSH Terms

Conditions

Asthma

Interventions

Propofol

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • XiaoFeng Shen, MD

    Nanjing Medical University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 8, 2008

First Posted

May 13, 2008

Study Start

April 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

March 31, 2009

Record last verified: 2009-03

Locations

CN(1)