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临床试验/NCT06567587
NCT06567587已完成不适用

Assessing the Efficacy of Dexmedetomidine in Alleviating Agitation for Exacerbated COPD Patients Who Are Treated for Psychosis Requiring Non- Invasive Ventilation

Tanta University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年6月10日最近更新:
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
入组人数
70
试验地点
2
主要终点
Primary outcome

研究概览

简要总结

Many studies approved dexmedetomodine as a drug controlled agitation for psychotic patients and also for patients on non invasive ventilation.

So we study the same effect on agitated patients who are on non invasive ventilation and also suffer of psychosis as agitation become more aggressive than usual

详细描述

Chronic obstructive pulmonary disease (COPD) characterized by progressive airflow limitation and tissue destruction as there are structural lung changes due to chronic inflammation from prolonged exposure to noxious particles or gases most commonly cigarette smoke. Chronic inflammation causes airway narrowing and decreased lung recoil. The disease often presents with symptoms of cough, dyspnea, and sputum production and may be exacerbated to cause respiratory failure. Acute exacerbations of chronic obstructive pulmonary disease can range from self-limited diseases to episodes of florid hypercapnic respiratory failure requiring non-invasive ventilation and late may be mixed type of respiratory failure due to hypercarbia and hypoxia and patients may need invasive ventilation.Hypercapnia generates increased sympathetic tone and decreased parasympathetic tone, it may be due to increases in brain glutamine and gamma-aminobutyric acid and this causes state of agitation and delirium. agitated COPD patients present a unique challenge due to the interplay between respiratory distress and psychiatric symptoms, which can complicate treatment.

Dexmedetomidine, a selective alpha-2 adrenergic agonist with sedative and analgesic properties by decreasing glutamate release and also it lacks GABA receptor modulation or cholinergic receptor activity. Additionally, dexmedetomidine may promote natural sleep patterns through stimulation of α 2 receptors leading to inhibition of noradrenergic neurons in the locus ceruleus and disinhibition of GABA neurons in the ventrolateral preoptic nucleus.The RASS is a 10-point scale ranging from -5 to +4. Levels -1 to -5 denote 5 levels of sedation, starting with"awakens to voice" and ending with "unarousable. Levels +1 to +4 describe increasing levels of agitation.

The lowest level of agitation starts with apprehension and anxiety, and peaks at combative and violent. RASS level 0 is "alert and calm. Psychiatric disorders are a category of behavioral and psychological syndromes that reflect underlying psychobiological dysfunction, leading to significant distress and impairment . Patients with pre-existing psychiatric disorders have an increased risk of poor health outcomes during an ICU stay, including increased odds of mechanical ventilation, organ dysfunction, and mortality, compared to patients without psychiatric disorders .This study aims to fill this gap by assessing the impact of dexmedetomidine on both respiratory parameters and psychiatric symptoms, with the goal of improving overall patient outcomes and guiding future treatment approaches in this complex.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients aged 18 - 60 years, ASA III (agitated and exacerbated COPD patients).

排除标准

  • •Patients with GCS < 8 (need invasive ventilation).
  • •Failure of non-invasive ventilation.
  • •Patients with fascial trauma or surgery.
  • •Patients with esophageal varices.
  • •Patients with recent GIT surgeries.

研究组 & 干预措施

Group II

35 psychotic patients on medical treatment came to ICU with exaggerated COPD and suffer delirium and agitation.

干预措施: BIPAP (Device)

Group I

35 Patients came to ICU with exaggerated COPD and suffer delirium and agitation

干预措施: BIPAP (Device)

Group I

35 Patients came to ICU with exaggerated COPD and suffer delirium and agitation

干预措施: Dexmedetomidine (Drug)

Group II

35 psychotic patients on medical treatment came to ICU with exaggerated COPD and suffer delirium and agitation.

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

Primary outcome

时间窗: 6 months

failure rate of patients necessitates invasive ventilation after non-invasive ventilation.

次要结局

  • Secondary outcome(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Zakarea Wfa

Lecturer of Anesthesia, Surgical ICU and Pain Medicine

Tanta University

研究点 (2)

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