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临床试验/NCT00676416
NCT00676416已完成不适用

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

Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2008年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Alveolar macrophage viability assay

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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).

研究组 & 干预措施

1

Propofol general anesthesia for asthmatic patients

干预措施: 2,6-Diisopropylphenol (Drug)

2

Propofol general anesthesia for non-asthmatic patients

干预措施: 2,6-Diisopropylphenol (Drug)

结局指标

主要结局

Alveolar macrophage viability assay

时间窗: One day prior to the surgery, immediately after anaesthesia, at the beginning and the end of the operation and one day after surgeries.

次要结局

  • Alveolar macrophage phagocytosis Assay(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(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(Before operation to the end of the surgery.)
  • Curve shape of CO2(Before operation to the end of the surgery.)
  • End-tidal CO2(Before operation to the end of the surgery.)

研究者

发起方
Nanjing Medical University
申办方类型
Other

研究点 (1)

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