Clinical trial NCT00676416: Influence of Propofol on Alveolar Macrophage in Asthmatic Patients
Official title: Influence of Propofol on Alveolar Macrophage Immunity in Asthmatic Patients Undergoing General Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: General anesthesia
Propofol
Immunity
Alveolar Macrophages
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: HRSA/Maternal and Child Health Bureau
First posted: 2008-05-13
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with or without asthma undergoing general anesthesia

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Alveolar macrophage viability assay
timeFrame: 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:
measure: Alveolar macrophage phagocytosis Assay
timeFrame: One day prior to the surgery, immediately after anaesthesia, at the beginning and the end of the operation and one day after surgeries.
measure: Alveolar macrophage cytokine Assay
timeFrame: One day before the surgery, immediately after anaesthesia, at the beginning and the end of the operation and one day after surgeries.
measure: Mean airway pressure
timeFrame: Before operation to the end of the surgery.
measure: Curve shape of CO2
timeFrame: Before operation to the end of the surgery.
measure: End-tidal CO2
timeFrame: Before operation to the end of the surgery.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternal and Child Health Care Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: XiaoFeng Shen, MD
role: STUDY_DIRECTOR
References: