Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06111300 |
| Other study ID # |
delirium in elderly patients |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2023 |
| Est. completion date |
October 31, 2025 |
Study information
| Verified date |
October 2023 |
| Source |
Assiut University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The Effect of Dexmedetomidine on the Incidence of Delirium Incidence of Post-operative
Delirium in Elderly Patients Undergoing Emergency Laparotomy
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.
