Dexmedetomidine Effect on Delirium of Elderly Patients

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06111300
Collaborator
(none)
86
2
24

Study Details

Study Description

Brief Summary

The Effect of Dexmedetomidine on the Incidence of Delirium Incidence of Post-operative Delirium in Elderly Patients Undergoing Emergency Laparotomy

Condition or Disease Intervention/Treatment Phase
Phase 4

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

Study Type:
Interventional
Anticipated Enrollment :
86 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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 (Participant)
Masking Description:
control group will take placebo
Primary Purpose:
Treatment
Official Title:
The Effect of Dexmedetomidine on the Incidence of Post-operative Delirium in Elderly Patients Undergoing Emergency Laparotomy
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Oct 31, 2024
Anticipated Study Completion Date :
Oct 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: group d

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.

Drug: Dexmedetomidine
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.

Placebo Comparator: group c

Patients in this group will receive volume- matched normal saline infusion (NaCL 0.9%) as a placebo.

Drug: Dexmedetomidine
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.

Outcome Measures

Primary Outcome Measures

  1. Delirium among elderly [3 days]

    Incidence of delirium among elderly patients undergoing emergency laparotomy.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • • Patients aged 60 years or older of either gender.

  • Patient undergoing emergency laparotomy either trauma or non-trauma patients.

Exclusion Criteria:
  • • 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.

  • Traumatic brain injury.

  • Intracranial bleeding < 1y.

  • Psychiatric illness.

  • History of alcohol or drug abuse.

  • Preoperative cerebrovascular accident with residual neurological deficit.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alaa Ahmed Gharib Ahmed, assisstant lecturer, Assiut University
ClinicalTrials.gov Identifier:
NCT06111300
Other Study ID Numbers:
  • delirium in elderly patients
First Posted:
Nov 1, 2023
Last Update Posted:
Nov 1, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 1, 2023