The Influence of Different Anesthetic Techniques on Cerebral Oxygenation During Spinal Surgery in a Prone Position With Controlled Hypotension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- regional cerebral oxygen saturation
研究概览
简要总结
Postural changes during anesthesia can lead to decreased cerebral blood flow and oxygenation, especially when moving from a supine to a prone position. This is particularly relevant during spinal surgery with controlled hypotension. Cerebral oximetry, monitored in the frontal cortex using an O3 sensor, is a noninvasive and continuous method to investigate the impact of anesthetic techniques on cerebral oxygenation in such scenarios.
详细描述
All patients will be monitored with standard monitoring, SedLine sedation monitor, and O3 regional oximeter, Masimo Corp, Irvine, CA. Fentanyl, propofol, and cisatracurium will be administered for anesthesia induction. Anesthetic agents will be maintained with intravenous anesthetic agents in one group and sevoflurane in another group to obtain the PSI 25-50. Mean blood pressure will be maintained 20-30% below baseline. MAP, HR, SpO2, ETCO2, and SrO2 will be assessed at supine position without oxygen administration (T1), supine position with oxygen administration (T2-baseline), intubation in the supine position (T3), just after prone positioning (T4), 10 minutes after prone positioning (T5), at the end of surgery in the prone position (T6) and at the end of anesthesia in the supine position (T7).
Data will be expressed as mean and standard deviation. The mean differences will be analyzed using the Student's T test for quantitative variables in those cases in which those variables followed a normal distribution. Distribution will be evaluated by Kolmogorov-Smirnoff's Z test. Differences in proportion will be conducted with contingency analysis using Chi-square and Fisher's exact test when needed.
A P-value < 0.05 will be statistically significant. Statistical analysis will be performed using the SPSS-PC statistical software program (version 15.0; SPSS, Inc., Chicago, IL, USA).
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 68 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) Physical Status I and II
- •Scheduled for elective spinal surgery
- •Prone position
- •General anesthesia with controlled hypotension.
排除标准
- •Hypertension
- •Coronary artery disease
- •Renal, hepatic, or cerebral insufficiency,
- •Patients with coagulopathy or receiving drugs affecting coagulation
- •Grossly anemic
- •Hypovolemic patients
- •Chronically diseased and debilitated patients,
- •Bleeding more than 200 mL
- •Hemodynamic instability (decrease of 25% of baseline mean arterial pressure [MAP] for three minutes)
- •Patients with significant baseline bradycardia.
结局指标
主要结局
regional cerebral oxygen saturation
时间窗: up to 24 weeks
By applying the sensors of regional cerebral oxygen saturation on the forehead.
次要结局
未报告次要终点
研究者
Mohamed Daabiss
Principal investigator
Prince Sultan Military Medical City
