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OpenTrials
Completed

NCT Number: NCT06567587

Dexmedtomodine Effect on Agitated Psychotic Patients Suffer COPD

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tanta

Tanta, 0020, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Dexmedetomidine

Drug

Effect o dexmedetomine on agitated normal and psychotic patients on BIPAP who are suffer exaggerated COPD

Other names: Precedex

BiPAP

Device

Put exaggerated COPD patients on non invasive ventillation

Other names: Non invasive ventiillation

Primary outcomes

  1. Primary outcome

    Time frame: 6 months

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

Secondary outcomes

  1. Secondary outcome

    Time frame: 6 months

    Richmond agitation score.

    • Effective doses of dexmedetomidine are needed to control agitation.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Collaborators

  • Laila Ahmed Abd-Elmotaleb El-Ahwal
  • Marwa Ahmed Abogabal

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 22, 2024
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.