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

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ClinicalTrials.gov Identifier: NCT00676416
Recruitment Status : Completed
First Posted : May 13, 2008
Last Update Posted : March 31, 2009
Sponsor:
Collaborator:
HRSA/Maternal and Child Health Bureau
Information provided by:
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.

Condition or disease Intervention/treatment
Asthma Drug: 2,6-Diisopropylphenol

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Influence of Propofol on Alveolar Macrophage Immunity in Asthmatic Patients Undergoing General Anesthesia
Study Start Date : April 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Propofol

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  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 Outcome Measures :
  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. ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00676416


Locations
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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
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Study Director: XiaoFeng Shen, MD Nanjing Medical University
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Responsible Party: XiaoFeng Shen, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT00676416    
Other Study ID Numbers: NMCHCH-0288-323
NMU-08-1090
First Posted: May 13, 2008    Key Record Dates
Last Update Posted: March 31, 2009
Last Verified: March 2009
Keywords provided by Nanjing Medical University:
General anesthesia
Propofol
Immunity
Alveolar Macrophages
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics