AsthmaPAMAPNCT00676416
Influence of Propofol on Alveolar Macrophage in Asthmatic Patients
An observational study of Asthma, run by Nanjing Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Asthma
- What is being tested?
- 2,6-Diisopropylphenol
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Apr 2008to Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients with or without asthma undergoing general anesthesia
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, 210004
About this study
Official title: Influence of Propofol on Alveolar Macrophage Immunity in Asthmatic Patients Undergoing General Anesthesia
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.
- Conditions
- Asthma
- Being tested
- 2,6-Diisopropylphenol
- Keywords
- General anesthesia, Propofol, Immunity, Alveolar Macrophages
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2,6-DiisopropylphenolDrug
Also called Diprivan
Propofol general anesthesia was performed in patients with asthma (1) and without asthma (2)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Propofol general anesthesia for asthmatic patients Receives: Drug: 2,6-Diisopropylphenol | |
| 2 | Propofol general anesthesia for non-asthmatic patients Receives: Drug: 2,6-Diisopropylphenol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar macrophage viability assay
Measured: 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 (5)
Alveolar macrophage phagocytosis Assay
Measured: One day prior to the surgery, immediately after anaesthesia, at the beginning and the end of the operation and one day after surgeries.
Alveolar macrophage cytokine Assay
Measured: One day before the surgery, immediately after anaesthesia, at the beginning and the end of the operation and one day after surgeries.
Mean airway pressure
Measured: Before operation to the end of the surgery.
Curve shape of CO2
Measured: Before operation to the end of the surgery.
End-tidal CO2
Measured: Before operation to the end of the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2008 (estimated)
- Study startApr 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- HRSA/Maternal and Child Health Bureau
- Investigators
- XiaoFeng Shen, MD, Study director, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676416
- Sponsor's protocol ID
- NMCHCH-0288-323
- Other IDs
- NMU-08-1090
- Acronym
- PAMAP
- Status last verified
- Mar 2009
- First submitted
- 8 May 2008
- Last updated
- 31 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Propofol on Alveolar Macrophage Immunity in Asthmatic Patients Undergoing General Anesthesia
- ClinicalTrials.gov ID
- NCT00676416
- Acronym / sponsor ID
- PAMAP / NMCHCH-0288-323
- Conditions
- Asthma
- Keywords
- General anesthesia, Propofol, Immunity, Alveolar Macrophages
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- HRSA/Maternal and Child Health Bureau
- Study start
- Apr 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 13 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: 2,6-DiisopropylphenolPropofol general anesthesia for asthmatic patients |
| 2 | – | Drug: 2,6-DiisopropylphenolPropofol general anesthesia for non-asthmatic patients |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with or without asthma undergoing general anesthesia
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2,6-DiisopropylphenolAlso: DiprivanPropofol general anesthesia was performed in patients with asthma (1) and without asthma (2) | Drug | 1, 2 |
Primary outcome
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.
5 secondary outcomes
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.
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.
Mean airway pressure
Time frame: Before operation to the end of the surgery.
Curve shape of CO2
Time frame: Before operation to the end of the surgery.
End-tidal CO2
Time frame: Before operation to the end of the surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
XiaoFeng Shen, MD study director
Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2009.