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Influence of Propofol on Alveolar Macrophage in Asthmatic Patients (PAMAP)

This study has been completed.
Sponsor:
Collaborator:
HRSA/Maternal and Child Health Bureau
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00676416
First received: May 8, 2008
Last updated: March 30, 2009
Last verified: March 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Asthma
 Drug: 2,6-Diisopropylphenol
 Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Influence of Propofol on Alveolar Macrophage Immunity in Asthmatic Patients Undergoing General Anesthesia

Resource links provided by NLM:

MedlinePlus related topics: Asthma
Drug Information available for: Propofol
U.S. FDA Resources

Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Mean airway pressure [ Time Frame: Before operation to the end of the surgery. ] [ Designated as safety issue: Yes ]
  • Curve shape of CO2 [ Time Frame: Before operation to the end of the surgery. ] [ Designated as safety issue: No ]
  • End-tidal CO2 [ Time Frame: Before operation to the end of the surgery. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: April 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Propofol general anesthesia for asthmatic patients
 Drug: 2,6-Diisopropylphenol
Propofol general anesthesia was performed in patients with asthma (1) and without asthma (2)
Other Name: Diprivan
2
Propofol general anesthesia for non-asthmatic patients
 Drug: 2,6-Diisopropylphenol
Propofol general anesthesia was performed in patients with asthma (1) and without asthma (2)
Other Name: Diprivan

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with or without asthma undergoing general anesthesia

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00676416

Locations
China, Jiangsu
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, China, 210004
Sponsors and Collaborators
Nanjing Medical University
HRSA/Maternal and Child Health Bureau
Investigators
Study Director: XiaoFeng Shen, MD Nanjing Medical University
  More Information

No publications provided

Responsible Party: XiaoFeng Shen, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT00676416     History of Changes
Other Study ID Numbers: NMCHCH-0288-323, NMU-08-1090
Study First Received: May 8, 2008
Last Updated: March 30, 2009
Health Authority: China: Ethics Committee

Keywords provided by Nanjing Medical University:
General anesthesia
Propofol
Immunity
Alveolar Macrophages

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Anesthetics
 Propofol
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on May 21, 2013