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临床试验/NCT06111300
NCT06111300尚未招募4 期

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

Assiut University0 个研究点目标入组 86 人开始时间: 2023年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
入组人数
86
主要终点
Delirium among elderly

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

control group will take placebo

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Patients aged 60 years or older of either gender.
  • Patient undergoing emergency laparotomy either trauma or non-trauma patients.

排除标准

  • • 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 <
  • 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.

研究组 & 干预措施

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.

干预措施: Dexmedetomidine (Drug)

group c

Placebo Comparator

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

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

Delirium among elderly

时间窗: 3 days

Incidence of delirium among elderly patients undergoing emergency laparotomy.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alaa Ahmed Gharib Ahmed

assisstant lecturer

Assiut University

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