Role of neuroinflammation on postoperative neurocognitive disorders in neurosurgical patients: A prospective observational study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- to compare the preoperative (pre surgical incision) and postoperative (at 24 hours postoperative) neuroinflammatory markers in elective brain and spine surgeries
研究概览
简要总结
Delirium after surgery occurs in 10% to 60% of elderly postoperative patients. A metanalysis of 5589 patients who underwent intracranial surgery showed an incidence of POD ranging from 12 to 26% due to variation in clinical features and delirium assessment methods Most of these studies excluded patients with pre-existing cognitive dysfunction. Also, the representation of spinal surgeries in studies describing the incidence of POCD in non-cardiac surgeries is extremely small. There are no exclusive studies mentioning the incidence of POCD in spinal surgeries. An important risk factor for the development of PND is neuroinflammation.
The aim of this study is to study the neuroinflammatory changes in cranial and spinal surgeries and their association with occurrence of POD
Our primary objective is to compare the difference in the preoperative and postoperative neuroinflammatory markers during elective brain and spine surgeries in adult patients (study population).
Our secondary objectives are to evaluate if the difference in the degree of neuroinflammation between cranial and spinal surgeries affects the incidence of POD, DNCR, and PND at 1 and 6 months, respectively after surgery. We also intend to study the relationship of pain and sleep quality with inflammation and cognition among these patients.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •All adult consenting patients undergoing elective tumour resection surgeries and spinal cord surgeries.
排除标准
- •Patients below 18 years of age, refusal of consent, awake and emergency surgeries.
结局指标
主要结局
to compare the preoperative (pre surgical incision) and postoperative (at 24 hours postoperative) neuroinflammatory markers in elective brain and spine surgeries
时间窗: Preoperative (pre surgical incision) and postoperative (at 24 hours postoperative) neuroinflammatory markers [IL-33, Neurofilament light chain (Nf-L) and MMP 9] in elective brain and spine surgeries
次要结局
- correlation between pre-post change in neuroinflammatory markers and incidence of post-opertaive delirium (POD), Delayed cognitive neurocognitive recovery (DCNR), and postoperative neurocognitive dysfunction (PND) at 6 months after cranial and spinal surgeries.(Montreal Cognitive Assessment (MOCA) (Annexure-1) will be used to assess baseline neurocognitive disorder (NCD) and POD between the 2nd -3rd, and 5th -7th postoperative day or at the time of discharge, whichever is earlier.)
- to study the relationship between sleep, inflammation and POD(Assessment of sleep quality using the Richard Campbell sleep questionnaire (RCBSQ) will be done in the pre-operative period and between the 2nd -3rd, and 5th -7th postoperative day or at the time of discharge, whichever is earlier)
- to study the relationship between pain, inflammation and POD(Assessment of pain using the Visual Analogue Scale (VAS) score will be done in the pre-operative period and between the 2nd -3rd, and 5th -7th postoperative day or at the time of discharge, whichever is earlier.)
研究者
Sangeetha RP
National Institute of Mental Health and Neurosciences