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临床试验/CTRI/2025/10/095648
CTRI/2025/10/095648尚未招募不适用

Evaluation Of Preoperative Nebulized Dexmedetomidine for the prevention of postoperative delirium in elderly patients undergoing surgery under general anesthesia - A Randomized Control Trial

Academic Investigator Initiated study1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2025年10月18日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
180
试验地点
1
主要终点
To determine the efficacy of preoperative dexmedetomidine nebulization in reducing the incidence of postoperative delirium

研究概览

简要总结

Post operative mental and behavioral abnormalities are generally divided into three situations: Emergence delirium, Post operative delirium and post operative cognitive dysfunction (1). Postoperative delirium (POD) is a common and significant complication, characterized by acute disturbances in attention, awareness, and cognition, typically occurring between postoperative days 1 and 5. (2). Surgical trauma, anesthesia, pain, disturbances in sleep patterns, changes in nutrition and delirium-inducing drugs such as high-dose narcotics, benzodiazepines and anticholinergics further contribute to the development of neurocognitive insults particularly in high-risk patients. Patients over 60 years old and those with preexisting conditions such as dementia, cardiovascular disease, diabetes and anemia are particularly vulnerable. POD can prolong recovery times, delayed discharge from the ICU and increase hospital stays overall affecting functional independence & quality of life. So, effective prevention of post operative delirium not only enhances patient safety and recovery but also reduces health care costs.

The pathophysiology of postoperative delirium (POD) is believed to be multifactorial, involving neuroinflammation, systemic stress responses, and micro emboli or watershed strokes. (4). Dexmedetomidine exerts its neuroprotective effects through multiple mechanisms primarily via selective alpha2-adrenergic receptor agonism, by reducing norepinephrine release. This leads to its both analgesic and sedative properties. It also reduces the release of substance P and mitigates nociceptive signaling. Dexmedetomidine interacts with imidazoline type 2 (I2) receptors potentially regulating calcium levels and mitigating endoplasmic reticulum stress-induced apoptosis which may protect against neuronal damage. It modulates neurotransmitter pathways and studies show that patients treated with dexmedetomidine has limited decrease in acetylcholinesterase (Ache) and butyrylcholinesterase (B.Ch.E.) activity. This limits inflammation and the systemic stress response to surgical trauma. (5)

Several drugs, including melatonin, ramelteon, acetaminophen, neostigmine and corticosteroids, are being studied for preventing postoperative delirium, but dexmedetomidine has the strongest evidence supporting its effectiveness in prevention of POD. (6)

However, there is limited research on the use of nebulized dexmedetomidine for preventing post operative delirium in adults. Therefore, this study aims to assess the efficacy of preoperative dexmedetomidine nebulization in preventing post operative delirium in elderly patients undergoing surgeries under general anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
60.00 Year(s) 至 98.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients consent to participate in the study.
  • 2.Elderly patients of age more than 60 years.
  • 3.Patients belonging to ASA 1,2, 3 4.Patients scheduled for elective surgeries under General Anesthesia.

排除标准

  • 1.Allergic to dexmedetomidine.
  • Heart block greater than first degree, Preexisting bradycardia with Heart rate less than
  • 3.History of Cognitive impairment like dementia, delirium, major stroke.
  • 4.Use of anti-psychotics, antidepressants 5.Kidney or liver disease.
  • 6.Body mass index more than 35 Kilogram per square Meter.
  • 7.Intracranial surgeries.
  • 8.Emergency surgeries.

结局指标

主要结局

To determine the efficacy of preoperative dexmedetomidine nebulization in reducing the incidence of postoperative delirium

时间窗: At the end of study duration data will be collected study duration 12 months

次要结局

  • To assess the hemodynamical stability including incidence of adverse events such as hypotension and bradycardia(At the end of study duration data will be collected study duration 12 months)

研究者

发起方
Academic Investigator Initiated study
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Dr Geetha Muniraju

Fortis Hospital Limited

研究点 (1)

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