Effects of Vasopressor on Cerebral Oxygenation During General Anesthesia in Abdominal Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Continual changes in Cerebral Oxygen Saturation
研究概览
简要总结
The purpose of this study is to investigate whether norepinephrine(N), phenylephrine(P) or ephedrine(E) have different effect on cerebral oxygenation in abdominal surgery with propofol or sevoflurane.
详细描述
This study was a single-center, randomized, double-blinded, controlled trial. First, the effects of E, P, or N on cerebral oxygen saturation(rScO2) under general anesthesia in abdominal surgery were studied. Patients with abdominal surgery were evaluated using near-infrared spectroscopy. Continual changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP), heart rate (HR), stroke volume (SV), cardiac output (CO) and systemic vascular resistance (SVR) will be measured with LiDCO rapidV3 monitoring system. To investigate the individualized therapeutic options & specific mechanisms of the three vasopressors on rScO2 and CO.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-III, age 18-80 years
- •Elective abdominal surgery
- •Signed informed consent
排除标准
- •Preoperative unstable blood hemodynamics
- •Allergy to ephedrine, phenylephrine or norepinephrine
- •Decrease in MAP <20%
- •Severe cardiovascular disorder
研究组 & 干预措施
Ephedrine-Propofol
receive ephedrine 0.15mg/kg (configured concentration 6mg/mL) when MAP was a 20% decrease in baseline blood pressure after both induction of anesthesia and tracheal intubation.
干预措施: Ephedrine-P (Drug)
Phenylephrine-propofol
receive phenylephrine 2.5ug/kg(configured concentration 100ug/mL) when MAP was a 20% decrease in baseline blood pressure after both induction of anesthesia and tracheal intubation.
干预措施: Phenylephrine-P (Drug)
Norepinephrine-propofol
receive norepinephrine 0.2ug/kg(configured concentration 8μg/ml) when MAP was a 20% decrease in baseline blood pressure after both induction of anesthesia and tracheal intubation.
干预措施: Norepinephrine-P (Drug)
Ephedrine-sevoflurane
receive Ephedrine 0.15mg/kg(configured concentration 6mg/mL) when MAP was a 20% decrease in baseline blood pressure after both induction of anesthesia and tracheal intubation.
干预措施: Ephedrine-S (Drug)
Phenylephrine-sevoflurane
receive phenylephrine 2.5ug/kg(configured concentration 80ug/mL) when MAP was a 20% decrease in baseline blood pressure after both induction of anesthesia and tracheal intubation.
干预措施: Phenylephrine-S (Drug)
Norepinephrine-sevoflurane
receive norepinephrine 0.2ug/kg(configured concentration 8ug/mL) when MAP was a 20% decrease in baseline blood pressure after both induction of anesthesia and tracheal intubation.
干预措施: Norepinephrine-S (Drug)
结局指标
主要结局
Continual changes in Cerebral Oxygen Saturation
时间窗: 10 minutes after entering the operating room; when 20% decrease in baseline MAP after both induction of anesthesia and intubation; when MAP rising to the highest point after administration of vasopressors
This outcome is measured by near-infrared spectroscopy
次要结局
- Continual changes in heart rate (HR)(10 minutes after entering the operating room; when 20% decrease in baseline MAP after both induction of anesthesia and intubation; when MAP rising to the highest point after administration of vasopressors)
- Continual changes in cardiac output (CO)(10 minutes after entering the operating room; when 20% decrease in baseline MAP after both induction of anesthesia and intubation; when MAP rising to the highest point after administration of vasopressors)
- Continual changes in stroke volume (SV)(10 minutes after entering the operating room; when 20% decrease in baseline MAP after both induction of anesthesia and intubation; when MAP rising to the highest point after administration of vasopressors)
- Continual changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP)(10 minutes after entering the operating room; when 20% decrease in baseline MAP after both induction of anesthesia and intubation; when MAP rising to the highest point after administration of vasopressors)
- Continual changes in systemic vascular resistance (SVR)(10 minutes after entering the operating room; when 20% decrease in baseline MAP after both induction of anesthesia and intubation; when MAP rising to the highest point after administration of vasopressors)
研究者
Liping Han
Professor & Vice Director
Dalian Municipal Central Hospital