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Completed

NCT Number: NCT00676416

Influence of Propofol on Alveolar Macrophage in Asthmatic Patients

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Nanjing Maternal and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

2,6-Diisopropylphenol

Drug

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

Other names: Diprivan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Mean airway pressure

    Time frame: Before operation to the end of the surgery.

  4. Curve shape of CO2

    Time frame: Before operation to the end of the surgery.

  5. End-tidal CO2

    Time frame: Before operation to the end of the surgery.

Sponsors and collaborators

Lead sponsor

Nanjing Medical University

Other

Collaborators

  • HRSA/Maternal and Child Health Bureau

Registry information

Official study title

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

Acronym: PAMAP

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 13, 2008
Registry last updated
Mar 31, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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