Delirium in Old AgePhase 4NCT06111300
Dexmedetomidine Effect on Delirium of Elderly Patients
A Phase 4 study testing Dexmedetomidine in people with Delirium in Old Age, run by Assiut University.
Trial summary
The Effect of Dexmedetomidine on the Incidence of Delirium Incidence of Post-operative Delirium in Elderly Patients Undergoing Emergency Laparotomy Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Delirium in Old Age
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 31 Oct 2025
- Phase
- Phase 4
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patients aged 60 years or older of either gender.
- Patient undergoing emergency laparotomy either trauma or non-trauma patients.
Who cannot join
- • Patients unable to provide written consent.
- Patients less than 60 years.
- Known drug intolerance or allergy to dexmedetomidine.
- Patients previously diagnosed to suffer from major neurocognitive disorder, defined by a mini-mental state examination (MMSE) score < 24.
- Severe audiovisual impairment.
- Child C chronic liver disease.
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- Traumatic brain injury.
- Intracranial bleeding < 1y.
- Psychiatric illness.
- History of alcohol or drug abuse.
- Preoperative cerebrovascular accident with residual neurological deficit.
About this study
Official title: The Effect of Dexmedetomidine on the Incidence of Post-operative Delirium in Elderly Patients Undergoing Emergency Laparotomy
The Effect of Dexmedetomidine on the Incidence of Delirium Incidence of Post-operative Delirium in Elderly Patients Undergoing Emergency Laparotomy
Read the detailed description
Delirium is an acute brain illness, which involves changes in consciousness, attention, cognition, and perception. Delirium is a common postoperative complication, especially in older patients, and is an independent predictor for postoperative mortality. It may put patients at risk of post-operative cognitive dysfunction (POCD) , Conversion rates to dementia up to 70% have been demonstrated in patients who are aged ≥ 65 y.The incidence of postoperative delirium ranges from 5% to 51% For major open abdominal surgery. Post-operative delirium (POD) is associated with: increased mortality; prolonged hospital stay; and major peri-operative complications and morbidity. For every day of postoperative delirium on the ICU, 1-year survival probability decreases by approximately 10%. it has multiple associated features including altered arousal, disorganised thinking, perceptual disturbances, psychosis, and sleep-wake cycle disturbance. Delirium occurs in patients of all ages but the highest incidence is in older people with a background of chronic central nervous system (CNS) disease. Several hypotheses describe different aspects of the pathophysiology of delirium; Increased Age: lead to diminished physiologic reserve and increased vulnerability to physical stress, decreased brain blood perfusion, increased neuron loss, and changes in the proportion of stress-regulating neurotransmitters. Neuroinflammation: Peripheral inflammatory insults damage endothelial cell-cell adhesions at the blood-brain barrier. The increased endothelial permeability promotes inflammation in the central nervous system, causing further damage, ischemia, and neuronal death.Reactive Oxidation Species: are a mediator of cellular damage due to its high lipid content and low antioxidant capacity.Circadian Rhythm Dysregulation: Disruption in sleep duration leads to dysfunction of many systems including regulation of sleep-wake cycles, glucose regulation, core body temperature, antioxidant defenses, and immune system response.Neurotransmitter Imbalance: Delirium is associated with decreased acetylcholine and increased dopamine activity. Neuroendocrine: Increased glucocorticoid release in response to physiologic stress increases the vulnerability of neurons to subsequent damage and impacts the regulation of gene transcription, cellular signaling, and glial cell behavior.Management of deliriumNon-pharmacologic interventions; which are the main treatments for delirium : Decreasing environmental disturbances, increase uninterrupted sleep by use of eyeglasses or hearing aids to optimize hearing and vision, use of tools to improve orientation including clocks and calendars, frequent mobilization.pharmacologic therapies such as; Benzodiazepines, Antipsychotics and Other medications include; haloperidol, quetiapine, and risperidone.Dexmedetomidine is a highly potent a2-agonist, which is used widely in critical care for delirium symptom control. It is known for its sparing properties on delirogenic medication such as sedatives and opioids. Furthermore, it displays antisympathetic, co-analgesic, anxiolytic and sedative effects with minimal respiratory depression. These effects are likely mediated by centraly inhibitive effects of dexmedetomidine on the nucleus coeruleus in the brain.Recent meta-analyses show a significantly lower incidence of delirium for dexmedetomidine when given intra- and postoperatively. Peng et al. also found a significant reduction in 30-day mortality and ICU and hospital stay in cardiac surgical patients.
- Conditions
- Delirium in Old Age
- Being tested
- Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Group D (dexmedetomidine group): Patients in this group will receive loading dose of dexmedetomidine 0.7 ug/kg over 10 min. then maintenance dose 0.2 - 1 ug/kg/hr till end of surgery. Group C (control group): Patients in this group will receive volum- matched normal saline infusion (NaCL 0.9%) as a placebo.
| Study group | Role | What they receive |
|---|---|---|
| group d | Experimental | Patients in this group will receive loading dose of dexmedetomidine 0.7 ug/kg over 10 min. then maintenance dose 0.2 - 1 ug/kg/hr till end of surgery. Receives: Drug: Dexmedetomidine |
| group c | Placebo comparator | Patients in this group will receive volume- matched normal saline infusion (NaCL 0.9%) as a placebo. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium among elderly
Incidence of delirium among elderly patients undergoing emergency laparotomy.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start1 Nov 2023 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium in Old AgeStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group D (dexmedetomidine group): Patients in this group will receive loading dose of dexmedetomidine 0.7 ug/kg over 10 min. then maintenance dose 0.2 - 1 ug/kg/hr till end of surgery.Group C (control group): Patients in this group will receive volum- matched normal saline infusion (NaCL 0.9%) as a placebo.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Ahmed Gharib Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111300
- Sponsor's protocol ID
- delirium in elderly patients
- Status last verified
- Oct 2023
- First submitted
- 11 Oct 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomidine on the Incidence of Post-operative Delirium in Elderly Patients Undergoing Emergency Laparotomy
- ClinicalTrials.gov ID
- NCT06111300
- Acronym / sponsor ID
- delirium in elderly patients
- Conditions
- Delirium in Old Age
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 1 Nov 2023 (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.
The Effect of Dexmedetomidine on the Incidence of Delirium Incidence of Post-operative Delirium in Elderly Patients Undergoing Emergency Laparotomy
Detailed description
Delirium is an acute brain illness, which involves changes in consciousness, attention, cognition, and perception. Delirium is a common postoperative complication, especially in older patients, and is an independent predictor for postoperative mortality. It may put patients at risk of post-operative cognitive dysfunction (POCD) , Conversion rates to dementia up to 70% have been demonstrated in patients who are aged ≥ 65 y.The incidence of postoperative delirium ranges from 5% to 51% For major open abdominal surgery. Post-operative delirium (POD) is associated with: increased mortality; prolonged hospital stay; and major peri-operative complications and morbidity. For every day of postoperative delirium on the ICU, 1-year survival probability decreases by approximately 10%. it has multiple associated features including altered arousal, disorganised thinking, perceptual disturbances, psychosis, and sleep-wake cycle disturbance. Delirium occurs in patients of all ages but the highest incidence is in older people with a background of chronic central nervous system (CNS) disease. Several hypotheses describe different aspects of the pathophysiology of delirium; Increased Age: lead to diminished physiologic reserve and increased vulnerability to physical stress, decreased brain blood perfusion, increased neuron loss, and changes in the proportion of stress-regulating neurotransmitters. Neuroinflammation: Peripheral inflammatory insults damage endothelial cell-cell adhesions at the blood-brain barrier. The increased endothelial permeability promotes inflammation in the central nervous system, causing further damage, ischemia, and neuronal death.Reactive Oxidation Species: are a mediator of cellular damage due to its high lipid content and low antioxidant capacity.Circadian Rhythm Dysregulation: Disruption in sleep duration leads to dysfunction of many systems including regulation of sleep-wake cycles, glucose regulation, core body temperature, antioxidant defenses, and immune system response.Neurotransmitter Imbalance: Delirium is associated with decreased acetylcholine and increased dopamine activity. Neuroendocrine: Increased glucocorticoid release in response to physiologic stress increases the vulnerability of neurons to subsequent damage and impacts the regulation of gene transcription, cellular signaling, and glial cell behavior.Management of deliriumNon-pharmacologic interventions; which are the main treatments for delirium : Decreasing environmental disturbances, increase uninterrupted sleep by use of eyeglasses or hearing aids to optimize hearing and vision, use of tools to improve orientation including clocks and calendars, frequent mobilization.pharmacologic therapies such as; Benzodiazepines, Antipsychotics and Other medications include; haloperidol, quetiapine, and risperidone.Dexmedetomidine is a highly potent a2-agonist, which is used widely in critical care for delirium symptom control. It is known for its sparing properties on delirogenic medication such as sedatives and opioids. Furthermore, it displays antisympathetic, co-analgesic, anxiolytic and sedative effects with minimal respiratory depression. These effects are likely mediated by centraly inhibitive effects of dexmedetomidine on the nucleus coeruleus in the brain.Recent meta-analyses show a significantly lower incidence of delirium for dexmedetomidine when given intra- and postoperatively. Peng et al. also found a significant reduction in 30-day mortality and ICU and hospital stay in cardiac surgical patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Group D (dexmedetomidine group): Patients in this group will receive loading dose of dexmedetomidine 0.7 ug/kg over 10 min. then maintenance dose 0.2 - 1 ug/kg/hr till end of surgery.Group C (control group): Patients in this group will receive volum- matched normal saline infusion (NaCL 0.9%) as a placebo.
| Arm | Type | Receives |
|---|---|---|
| group d | Experimental | Drug: DexmedetomidinePatients in this group will receive loading dose of dexmedetomidine 0.7 ug/kg over 10 min. then maintenance dose 0.2 - 1 ug/kg/hr till end of surgery. |
| group c | Placebo comparator | Drug: DexmedetomidinePatients in this group will receive volume- matched normal saline infusion (NaCL 0.9%) as a placebo. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- • Patients aged 60 years or older of either gender.
Key exclusion criteria (11 listed)
- • Patients unable to provide written consent.
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 |
|---|---|---|
| DexmedetomidineGroup D (dexmedetomidine group): Patients in this group will receive loading dose of dexmedetomidine 0.7 ug/kg over 10 min. then maintenance dose 0.2 - 1 ug/kg/hr till end of surgery. Group C (control group): Patients in this group will receive volum- matched normal saline infusion (NaCL 0.9%) as a placebo. | Drug | group c, group d |
Primary outcome
Delirium among elderly
Time frame: 3 days
Incidence of delirium among elderly patients undergoing emergency laparotomy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine in people with Delirium in Old Age, run by Assiut University.
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 2 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Delirium among elderly (time frame: 3 days). 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 1 Nov 2023.