Influence of Propofol on Alveolar Macrophage in Asthmatic Patients

Asthma Clinical Trial

— PAMAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00676416
• Other study ID #: NMCHCH-0288-323
• Secondary ID: NMU-08-1090
• Status: Completed
• Phase: Phase 4
• First received: May 8, 2008
• Last updated: March 30, 2009
• Start date: April 2008
• Est. completion date: March 2009

Study information

• Verified date: March 2009
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• 2,6-Diisopropylphenol
Propofol general anesthesia was performed in patients with asthma (1) and without asthma (2)

Locations

Country	Name	City	State
China	Nanjing Maternal and Child Health Care Hospital	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Nanjing Medical University	HRSA/Maternal and Child Health Bureau

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	Mean airway pressure		Before operation to the end of the surgery.	Yes
Secondary	Curve shape of CO2		Before operation to the end of the surgery.	No
Secondary	End-tidal CO2		Before operation to the end of the surgery.	Yes