Influence of Propofol on Alveolar Macrophage in Asthmatic Patients

Completed

• Conditions: Asthma
• Interventions: Drug: 2,6-Diisopropylphenol

• Registration Number: NCT00676416
• Lead Sponsor: Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-08
• Study First Submitted QC: 2008-05-12
• Study First Posted: 2008-05-13
• Status Verified: 2009-03
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Last Update Submitted: 2009-03-30
• Last Update Posted: 2009-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
2	2,6-Diisopropylphenol	Propofol general anesthesia for non-asthmatic patients
1	2,6-Diisopropylphenol	Propofol general anesthesia for asthmatic patients

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Nanjing Maternal and Child Health Care Hospital; 🇨🇳 Nanjing, Jiangsu, China