Effect of permissive hypotension on cerebral oxygenation and ischemic neurological injury during endoscopic pituitary surgeries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Incidence of cerebral desaturation events determined by number of patients who experience a decrease in rSO2 values to less than 80% of their baseline value or an absolute value less than 55% for more than 15 seconds, assessed with a non-invasive cerebral oximeter INVOSTM 7100
研究概览
简要总结
Permissive Hypotension (PH) is considered to be an essential prerequisite for obtaining a satisfcatory oligemic surgical field during prolonged endoscopic surgeries. Deliberate lowering of blood pressure to below normal, introduces a risk of cerebral hypoperfusion, decreased cerebral oxygenation and ischemic neuronal damage which can result in adverese neurological events such as postoperative cognitive impairment, neurological deficits, stroke, coma and even death. Presently there is a knowledge gap about the magnitude of the impact of controlled moderate permissive hypotension on cerebral oxygenation in patients undergoing these surgeries.
LACUNAE: To the best of our knowledge, no previous study has assessed the safety of PH in patients undergoing endoscopic pituitary surgeries.
Hence in this prospective observational study, we aim to investigate the potential impact of intraoperative PH on cerebral oxygenation, and ischemic neurological injury in this patient population
We will assess cerebral oxygenation intraoperatively during permissive hypotension with near infrared spectroscopy (NIRS) based cerebral oximetry. Ischemic neurological injury will be assessed clinically by detection of postoperative cognitive dysfunction using MMSE and MoCA scores. Serological markers of cerbral ischemia (NSE, S100B), and early predictors of acute and cardiac and kidney inury (hs-cTnT, NGAL) will also be assessed pre and postoperatively to determine the impact on vital organs.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •All ASA I and II patients greater than 18 years of age, scheduled for endoscopic transnasal transsphenoidal pituitary surgery.
排除标准
- •Patients with: Uncontrolled Hypertension History of obstructive sleep apnea (OSA) Preoperative hemoglobin levels <10 gm/dl Preoperative MMSE score ≤23 Preoperative MoCA score ≤25 History of cerebrovascular disease History of documented carotid artery disease History of anxiety and psychiatric illness History of ischemic heart disease, cardiac rhythm disturbances, intracardiac shunts.
- •Renal or hepatic dysfunction Anticipated difficult airway History of allergy or drug sensitivity.
结局指标
主要结局
Incidence of cerebral desaturation events determined by number of patients who experience a decrease in rSO2 values to less than 80% of their baseline value or an absolute value less than 55% for more than 15 seconds, assessed with a non-invasive cerebral oximeter INVOSTM 7100
时间窗: Cerebral oxygenation (rSO2) will be continuously monitored intraoperatively. | Every episode of CDE will be recorded. | Parameters recorded during CDE- | 1) rSO2 | 2) Hemodynamic parameters | 3) Duration of CDE | 4) Postintervention rSO2
次要结局
- Severity and duration of cerebral oxygen desaturation: by the Cumulative Saturation below Threshold(Intraoperative)
- Incidence of postoperative cognitive dysfunction : Mini- Mental State examination score (MMSE) and Montreal cognitive assessment (MoCA)(Preoperative and Postoperative after 24hours and 72 hours)
- Postoperative change in serum cerebral ischemia biomarkers levels: NSE, S100 B(Preoperative and postoperative)
- Postoperative change in serum renal and cardiac ischemia biomarker levels: NGAL, hs-cTnT(Preoperative and Postopeartive)
- Association between Decrease in mean arterial pressure and change in cerebral oxygen saturation (rSO2)(Intraoperative)
- Association between Cumulative Saturation below Threshold and postoperative cognitive dysfunction(Intraoperative)
- association between Cumulative Saturation below Threshold and change in the serum levels of cerebral ischemia biomarkers from baseline(Intraoperative)
- Comparison of effect of permissive hypotension on cerebral ischemia during endoscopic pituitary surgeries, between normotensive and controlled hypertensive patients(Intraoperative)
- Comparison of effect of permissive hypotension on cerebral ischemia during endoscopic pituitary surgeries, between patients with normal and impaired cerebral autoregulation(Intraoperative)
研究者
Dr Madhuri Garg
GB Pant Institute of Postgraduate Medical Education And Research