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临床试验/NCT06325462
NCT06325462已完成不适用

The Influence of Different Anesthetic Techniques on Cerebral Oxygenation During Spinal Surgery in a Prone Position With Controlled Hypotension

Prince Sultan Military Medical City1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2024年2月10日最近更新:
适应症

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

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

发起方
Prince Sultan Military Medical City
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Daabiss

Principal investigator

Prince Sultan Military Medical City

研究点 (1)

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