跳至主要内容
临床试验/NCT06809556
NCT06809556尚未招募不适用

Association of Processed Electroencephalography Derived Parameters with Postoperative Delirium in Patients with Parkinson's Disease Undergoing Elective Neurosurgery

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's0 个研究点目标入组 40 人开始时间: 2025年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
主要终点
Identification and quantification of the association between the presence of intraoperative burst suppression with the incidence of postoperative delirium

研究概览

简要总结

Patients with Parkinson's disease seem prone to developing postoperative delirium after surgery, the causes of which remain understudied and multifactorial. Anesthetic management remains challenging due to the changes in neurotransmitter levels in these patients which translate to altered drug effects. Avoiding excessive anesthesia is essential. Processed electroencephalography (EEG) is used worldwide along with our centre to monitor depth of anesthesia. It is non-invasive and easy to use. Some EEG patterns like "burst suppression" are easily identifiable and indicate that the brain has fallen into an excessively low metabolic state, which could mean increased anesthetic sensitivity. Appearance of "burst suppression" can predict delirium in non-neurosurgical procedures, but this has never been studied during surgery for deep brain stimulator insertion in Parkinson's disease patients. Through this study we wish to observe the association of EEG parameters with the development of postoperative delirium in this subset of the population.This has the capacity to change anesthetic practice by being mindful of the fragile brain of such patients and individualizing drug dosing for each patient to improve outcomes and reduce hospital stay.

详细描述

Postoperative delirium is a multifactorial condition, with incidence ranging from 20% to 50%. Unfortunately, the implications of postoperative delirium extend beyond the immediate perioperative period. Bickel et al observed in their three-year follow-up that patients experiencing postoperative delirium (POD) exhibited cognitive decline and had an elevated risk of developing dementia compared to those without delirium after orthopedic surgeries.

Parkinson's disease is a neurodegenerative disorder that has been associated with an increased risk of developing delirium, with a prevalence rate of 34%. The incidence of postoperative delirium in this subset, reported after DBS in Parkinson's patients, ranges from approximately 22% to as high as ~43%. Patients with Parkinson's disease commonly undergo various elective surgical procedures, including deep brain stimulation (DBS) electrode insertion. The anesthetic management for DBS generally involves monitored anesthesia care with mild sedation, followed by patient awakening for microelectrode recording (MER) to ensure optimal electrode positioning. Increased propensity for postoperative delirium in these patients with Parkinson's has prompted foray into its predictive factors.

Intraoperative EEG has demonstrated significant promise as a predictor of postoperative delirium, especially in the elderly. A systematic review and meta-analysis by Likhvantsev et al found that the presence of burst suppression was associated with a 41% increase in the relative risk of POD, and the duration of burst suppression correlated with a higher occurrence of postoperative cognitive dysfunction (POCD). Presence and duration of burst suppression in the intraoperative period was found to be an independent predictor of postoperative delirium. In instances of delirium occurring in the absence of burst suppression, low absolute and relative frontal alpha power have been associated with its incidence.

Interestingly, all previous studies were conducted in patients without preexisting neurological conditions, with minimal literature focusing on intraoperative processed EEG in patients with Parkinson's. In an observational study by Astalosch et al, intraoperative burst suppression was found to be an influencer for the severity of delirium. There exists a significant gap in the evidence regarding the utility of intraoperative EEG-derived parameters in predicting the occurrence of delirium in Parkinson's disease.

Postoperative delirium, along with causing increased morbidity and longer hospital stay, could also lead to long-term effects, such as cognitive decline and increased vulnerability to dementia. And in patients with Parkinson's, due to consequence of delirium, there are reports higher mortality rate as compared to healthy individuals. Despite the recognized higher incidence of delirium and its effects in this patient population, there is a notable lack of research exploring intraoperative EEG-based predictors. This study aims to investigate the utility of presence of burst suppression, (along with various other processed EEG based parameters) as potential indicators of postoperative delirium in patients undergoing DBS. By exploring these factors, we hope to identify reliable markers of postoperative delirium that help us identify patients at risk, refine anesthetic techniques to minimize risk, ultimately enhance the quality of care provided to this particularly vulnerable set of patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • •Diagnosis of Parkinson's disease
  • •Elective neurosurgery for implantation of DBS electrodes and implantable pulse generator (IPG) device.
  • •18 years of age or older

排除标准

  • •Refusal/withdrawal of consent
  • •Inability to place sensor/ record EEG for the entire duration of surgery
  • •Emergency surgery
  • •Redo surgery
  • •Preoperative delirium (defined as per 3D CAM score)

结局指标

主要结局

Identification and quantification of the association between the presence of intraoperative burst suppression with the incidence of postoperative delirium

时间窗: During surgery to 24 hours postoperative

Identification and quantification of the association between the presence of intraoperative burst suppression with the incidence of postoperative delirium. This will be measured by evaluating the presence of burst suppression readings found during intraoperative EEG monitoring and determining whether the readings are associated with the development of postoperative delirium (measured by the administration of the 3D CAM and MoCA tools).

次要结局

  • Determining the association of postoperative delirium with other parameters on perioperative processed EEG(During surgery to 24 hours postoperative)

研究者

发起方
London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sujoy Banik

Anesthesiologist, Assistant Professor

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

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