Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06567587
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Dexmedtomodine Effect on Agitated Psychotic Patients Suffer COPD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessing the Efficacy of Dexmedetomidine in Alleviating Agitation for Exacerbated COPD Patients Who Are Treated for Psychosis Requiring Non- Invasive Ventilation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 ventilationHypercapnia 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 nucleusThe RASS is a 10-point scale ranging from -5 to 4 Levels -1 to -5 denote 5 levels of sedation starting withawakens 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
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 nucleusThe RASS is a 10-point scale ranging from -5 to 4 Levels -1 to -5 denote 5 levels of sedation starting withawakens 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None