Assessment of cerebrovascular reserve and clinical outcomes after elective supratentorial tumour surgeries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- NIMHANS
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- To assess pre-operative cerebrovascular reserve by breath holding index in patients undergoing elective supratentorial tumour surgeries and comparing it with the post-operative neurological deficits. (new onset as well as worsening of pre-existing neurological deficits).
研究概览
简要总结
Intracranial tumors often impair cerebral autoregulation, especially in the regions adjacent to the tumors. This impairment can affect the brain’s ability to regulate blood flow in response to increased metabolic demand or stimuli, a capacity known as cerebrovascular reserve. Previous studies have shown that this reserve is often compromised in patients with supratentorial tumors. While some research has explored the immediate effects of tumor decompression on cerebrovascular reserve, there is limited data on long-term outcomes and the potential link between impaired reserve and postoperative neurological deficits. This study investigates the relationship between preoperative cerebrovascular reserve and postoperative neurological deficits in patients undergoing elective supratentorial brain tumor surgeries. The study hypothesizes that patients with impaired preoperative cerebrovascular reserve are more likely to develop new or worsening postoperative neurological deficits. The aim is to assess preoperative cerebrovascular reserve and correlate it with the incidence of postoperative neurological deficits. Additionally, the study will examine the relationship between preoperative autonomic dysfunction and postoperative outcomes, as well as changes in cerebrovascular reserve three months after surgery. This prospective observational study will be conducted at the National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, involving adult patients aged 50 to 80 years undergoing elective supratentorial tumor surgeries. The cerebrovascular reserve will be assessed by calculating the Breath Holding Index (BHI) using Transcranial Doppler (TCD). Autonomic function will be assessed from measuring the patient’s heart rate variability in the pre-operative period. The results from this study will provide valuable insights into the impact of impaired cerebrovascular reserve on postoperative neurological outcomes and the potential role of autonomic dysfunction in these patients.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 50.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •incudes al adult males and females aged between 50 and 80 years undergoing elective supratentorial tumour surgery at NIMHANS.
排除标准
- •1.absent transtemporal transcranial doppler window 2.patients not co-operating for transcranial doppler examination 3.unable to hold breath for atleast 15 seconds 4.undergoing endoscopic pituitary surgery, awake craniotomy, epilepsy surgery 5.loss to follow up at 3 months 6.absence of written informed consent 7.glasgow coma score less than 15.
结局指标
主要结局
To assess pre-operative cerebrovascular reserve by breath holding index in patients undergoing elective supratentorial tumour surgeries and comparing it with the post-operative neurological deficits. (new onset as well as worsening of pre-existing neurological deficits).
时间窗: 1.Breath holding index at pre-operative period and at 3 months follow up. | 2.Neurological examination at pre-operative period, at discharge, and 3 months follow up.
次要结局
- To correlate the post-operative neurological deficits (new onset, as well as worsening of pre-existing neurological deficits) to the preoperative autonomic dysfunction(1.Neurological examination at pre-operative period, at discharge and at 3 months follow up.)
- To assess changes in cerebrovascular reserve at 3 months after surgery and its comparison to pre-operative status(1.Cerebrovascular reserve assessment at pre-operative period, and at 3 months follow-up.)
研究者
Protiti Chatterjee
National Institute of Mental Health & Neurosciences