Dexmedtomodine Effect on Agitated Psychotic Patients Suffer COPD

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

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

Study Overview

• Status: Completed
• Conditions: Response of Agitated Patients to Dexmedetomidine
• Intervention / Treatment: Drug: Dexmedetomidine; Device: BIPAP

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 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.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Egypt
  • Tanta
    • Tanta, Tanta, Egypt, 0020
      • Tanta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients who will meet the previous criteria will be enrolled in the study. Patients will be classified into two equal groups; 35 patients will be enrolled in each group; all patients will receive loading dose of dexmedetomidine 1 μg/kg in 10 min then maintenance dose 0.2-0.7 μg/kg/hr till obtain adequate sedation level guided by Richmond agitation score.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group I; 35 Patients came to ICU with exaggerated COPD and suffer delirium and agitation	Drug: Dexmedetomidine; Effect o dexmedetomine on agitated normal and psychotic patients on BIPAP who are suffer exaggerated COPD; Other Names: Precedex; Device: BIPAP; Put exaggerated COPD patients on non invasive ventillation; Other Names: Non invasive ventiillation
Group II; 35 psychotic patients on medical treatment came to ICU with exaggerated COPD and suffer delirium and agitation.	Drug: Dexmedetomidine; Effect o dexmedetomine on agitated normal and psychotic patients on BIPAP who are suffer exaggerated COPD; Other Names: Precedex; Device: BIPAP; Put exaggerated COPD patients on non invasive ventillation; Other Names: Non invasive ventiillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary outcome	failure rate of patients necessitates invasive ventilation after non-invasive ventilation.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary outcome	Richmond agitation score. • Effective doses of dexmedetomidine are needed to control agitation.	6 months

Collaborators and Investigators

• Sponsor: Tanta University
• Collaborators: Laila Ahmed Abd-Elmotaleb El-Ahwal; Marwa Ahmed Abogabal

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2024
• Primary Completion (Actual): November 10, 2024
• Study Completion (Actual): March 10, 2025

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Aberrant Motor Behavior in Dementia; Neurologic Manifestations; Nervous System Diseases; Behavioral Symptoms; Neurobehavioral Manifestations; Dyskinesias; Psychomotor Disorders; Psychomotor Agitation; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Dexmedetomidine
• Other Study ID Numbers: 36264PR678/5/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Dexmedetomidine effect on agitated psychotic COPD patients on non invasive ventillation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No