Randomized,Double-Blind Trial A Comparative Analysis of the Effects of Sevoflurane and Propofol on Optic Nerve Sheath Diameter During Steep Trendelenburg Position and Pneumoperitoneum for Laparoscopic Gynecologic Surgery
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Changes of ultrasonographic optic nerve sheath diameter
研究概览
简要总结
Intracranial pressure（ICP) increases during laparoscopic gynecologic surgery increase (ICP) and may alter optic nerve sheath diameter(ONSD).This study measures ONSD in different team because sevoflurane and propofol have different effects on ICP.Half of participants will receive sevoflurane anesthesia,while the other half undergo propofol anesthesia.
详细描述
Due to the anatomical and physiological characteristics of optic nerve sheath ,ONSD increases when ICP rises.
Sevoflurane and propofol have different effects on ICP.When sevoflurane concentration >1.1 minimum alveolar concentration（MAC),ICP increases because of cerebral vasodilatation；on the other hand ,propofol constricts the blood vessels and ICP decreases.
ICP increases during laparoscopic gynecologic surgery because of steep Trendelenburg position and pneumoperitoneum .
Meanwhile,sevoflurane affects self regulation of cerebral blood flow on the way of dose dependent,but propofol has no effects on self regulation of cerebral blood flow.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical status diagnosed as I or II
排除标准
- •neuromuscular diseases;laboratory abnormalities in electrolytes; liver and kidney dysfunction;allergy to general anesthetics;pregnancy;ocular lesions including ocular trauma, optic neuritis, optic nerve tumor.
研究组 & 干预措施
Team Sevoflurane
干预措施: Sevoflurane (Drug)
Team Propofol
干预措施: Propofol (Drug)
结局指标
主要结局
Changes of ultrasonographic optic nerve sheath diameter
时间窗: from the time when patients enter into operation room to the time when the surgery ending
different time including pre-anesthesia, after intubation,every 15 minutes in the first hour after beginning of surgery, every hour when one hour after surgery beginning,surgery ending.
次要结局
- Analyzed whether mean arterial pressure influence the change of ONSD based on 110 patients in two groups.(from the time when patients enter into operation room to the time when the surgery ending)
- Analyzed whether airway pressure influence the change of ONSD based on 110 patients in two groups.(from the time when patients enter into operation room to the time when the surgery ending)
- Analyzed whether urine volume influence the change of ONSD based on 110 patients in two groups.(from the time when patients enter into operation room to the time when the surgery ending)
- Analyzed whether blood loss influence the change of ONSD based on 110 patients in two groups.(from the time when patients enter into operation room to the time when the surgery ending)
- Analyzed whether fluid volume influence the change of ONSD based on 110 patients in two groups.(from the time when patients enter into operation room to the time when the surgery ending)
研究者
Weilian Geng
Director,Clinical Research
Obstetrics & Gynecology Hospital of Fudan University