Dexmedtomodine Effect on Agitated Psychotic Patients Suffer COPD

NCT06567587 | Completed FDA Drug FDA Device

• 1 other identifier: 36264PR678/5/24
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Response of Agitated Patients to Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Primary outcome

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

  6 months

Secondary Outcomes (1)

• Secondary outcome

  6 months

Study Arms (2)

Group I

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

Drug: Dexmedetomidine; Device: BIPAP

Group II

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

Drug: Dexmedetomidine; Device: BIPAP

Interventions

Dexmedetomidine DRUG

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

Also known as: Precedex

Group I; Group II

BIPAP DEVICE

Put exaggerated COPD patients on non invasive ventillation

Also known as: Non invasive ventiillation

Group I; Group II

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead
• Laila Ahmed Abd-Elmotaleb El-Ahwal: collaborator
• Marwa Ahmed Abogabal: collaborator

Study Sites (1)

Tanta

Tanta, Tanta, 0020, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Surgical ICU and Pain Medicine

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 22, 2024
• Study Start: June 10, 2024
• Primary Completion: November 10, 2024
• Study Completion: March 10, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

EG (1)