Response of Agitated Patients to DexmedetomidineNCT06567587
Dexmedtomodine Effect on Agitated Psychotic Patients Suffer COPD
An observational study of Response of Agitated Patients to Dexmedetomidine, run by Tanta University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Response of Agitated Patients to Dexmedetomidine
- What is being tested?
- Dexmedetomidine and BIPAP
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jun 2024to 10 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- Patients aged 18 - 60 years, ASA III (agitated and exacerbated COPD patients).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Being tested
- Dexmedetomidine, BIPAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Precedex
Effect o dexmedetomine on agitated normal and psychotic patients on BIPAP who are suffer exaggerated COPD
BIPAPDevice
Also called Non invasive ventiillation
Put exaggerated COPD patients on non invasive ventillation
| Study group | Role | What they receive |
|---|---|---|
| Group I | 35 Patients came to ICU with exaggerated COPD and suffer delirium and agitation Receives: Drug: Dexmedetomidine; Device: BIPAP | |
| Group II | 35 psychotic patients on medical treatment came to ICU with exaggerated COPD and suffer delirium and agitation. Receives: Drug: Dexmedetomidine; Device: BIPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
failure rate of patients necessitates invasive ventilation after non-invasive ventilation.
Measured: 6 months
Secondary outcomes (1)
Secondary outcome
Richmond agitation score.
- Effective doses of dexmedetomidine are needed to control agitation.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start10 Jun 2024
- Primary completion10 Nov 2024
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Response of Agitated Patients to DexmedetomidineStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Collaborators
- Laila Ahmed Abd-Elmotaleb El-Ahwal, Marwa Ahmed Abogabal
- Responsible party
- Principal investigator, Mohamed Zakarea Wfa, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567587
- Sponsor's protocol ID
- 36264PR678/5/24
- Status last verified
- Jan 2026
- First submitted
- 20 Aug 2024
- Last updated
- 13 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Dexmedetomidine effect on agitated psychotic COPD patients on non invasive ventillation
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of Dexmedetomidine in Alleviating Agitation for Exacerbated COPD Patients Who Are Treated for Psychosis Requiring Non- Invasive Ventilation
- ClinicalTrials.gov ID
- NCT06567587
- Acronym / sponsor ID
- 36264PR678/5/24
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Collaborators
- Laila Ahmed Abd-Elmotaleb El-Ahwal, Marwa Ahmed Abogabal
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 10 Nov 2024 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Drug: Dexmedetomidine, Device: BIPAP35 Patients came to ICU with exaggerated COPD and suffer delirium and agitation |
| Group II | – | Drug: Dexmedetomidine, Device: BIPAP35 psychotic patients on medical treatment came to ICU with exaggerated COPD and suffer delirium and agitation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- Patients aged 18 - 60 years, ASA III (agitated and exacerbated COPD patients).
Key exclusion criteria (5 listed)
- Patients with GCS < 8 (need invasive ventilation).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: PrecedexEffect o dexmedetomine on agitated normal and psychotic patients on BIPAP who are suffer exaggerated COPD | Drug | Group I, Group II |
| BIPAPAlso: Non invasive ventiillationPut exaggerated COPD patients on non invasive ventillation | Device | Group I, Group II |
Primary outcome
Primary outcome
Time frame: 6 months
failure rate of patients necessitates invasive ventilation after non-invasive ventilation.
1 secondary outcome
Secondary outcome
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: Undecided. Dexmedetomidine effect on agitated psychotic COPD patients on non invasive ventillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Response of Agitated Patients to Dexmedetomidine, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.