Comparison the Effect on Cerebral Oxygenation by Sevoflurane-remifentanil or Propofol-remifentanil Anesthesia Using Near-infrared Spectroscopy in Patients Undergoing Carotid Endarterectomy)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- cerebral oxygenation measured by near-infrared spectroscopy
研究概览
简要总结
The aim of this study is comparing the effect on cerebral oxygenation by sevoflurane-remifentanil or propofol-remifentanil anesthesia in patient undergoing carotid endarterectomy. Cerebral oxygenation is measured by near-infrared spectroscopy. Sevoflurane and propofol reduce the cerebral metabolic rate for oxygen in similar degree. Propofol decrease the cerebral blood flow by dose-dependent manner, however, sevoflurane increase the cerebral blood flow in the concentration of avobe 1 MAC. Both drugs are widely used in general anesthesia for neurosurgical procedure, and their effect on cerebral oxygenation are acceptable. There is little data about the effect of general anethetics on cerebral oxygenation in patients undergoing carotid endarterectomy, who have imparied cerebral circulation. Our hypothesis is sevoflurane will show better cerebral oxygenation than propofol in patient have impaired cerebral circulation.
详细描述
This study is performed by monitoring the cerebral oxygenation using near-infrared spectroscopy from general anesthesia induction to 10 min after releasing the carotid artery clipping.
Study group: Sevoflurane - remifentanil anesthesia group (S) Propofol - remifentanil anesthesia group (R)
Monitoring: near-infrared spectroscopy (SOMA sensor) BIS, HR, arterial blood pressure, SpO2, body temperature
Patient seletion
- inclusion criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologist (ASA) physical status 1-3
- •18 ~ 70 years
- •patient who agree with informed consent
排除标准
- •ASA physical status > 4
- •preoperative SpO2 < 97%
- •patient who has other neurologic disease not related to carotid endarterectomy
研究组 & 干预措施
Sevoflurane
adjust the end-tidal sevoflurane (sevofran inhaler, Hana pharmacy, Korea) concentration maintaining the 40 ~ 50 BIS (bispectral index) with 3 ng/ml of remifentanil using TCI (target controlled infusion) pump
干预措施: Sevoflurane (Drug)
Propofol
adjust propofol (FRESOFOL MCT INJ 2% (vial), Fresinus Kabi Korea) concentration maintaining the 40 ~ 50 BIS (bispectral index) with 3 ng/ml of remifentanil using TCI (target controlled infusion) pump
干预措施: Propofol (Drug)
结局指标
主要结局
cerebral oxygenation measured by near-infrared spectroscopy
时间窗: one year
次要结局
未报告次要终点
研究者
Seongtae Jeong
Associated professor, Anesthesiolgoy and Pain Medicine
Chonnam National University Hospital