The Effect of Blood Pressure on Cerebral Perfusion and Oxygenation During Vascular Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Middle cerebral artery blood velocity
研究概览
简要总结
Anesthesia reduces blood pressure and cerebral blood flow is normally considered to be maintained despite marked changes in blood pressure. Vascular surgical patients are often elderly, have high blood pressure and atherosclerosis and in these patients cerebral blood flow may decrease if blood pressure is reduced during anesthesia. The purpose of this study is to assess the effect of blood pressure for preservation of cerebral blood flow during anesthesia in vascular surgery. The hypothesis is that in vascular surgical patients, during anesthesia, cerebral blood flow is higher with blood pressure maintained at a higher level than that used in normal clinical practice.
详细描述
Background: Induction of anesthesia reduces mean arterial pressure (MAP) and cerebral blood flow is normally considered to be maintained by cerebral autoregulation despite changes in MAP between 60 - 150 mmHg and standard of care during anesthesia is to maintain MAP above 60 mmHg. Vascular surgical patients are often elderly with hypertension and atherosclerotic manifestations that may impair cerebral autoregulation of importance for anesthesia-induced reduction in blood pressure.
Objective
To assess the effect of MAP for preservation of cerebral blood flow and oxygenation during vascular surgery.
Hypothesis
The primary hypothesis is that during general anesthesia in vascular surgical patients, cerebral blood flow velocity and oxygenation is higher with MAP maintained at 80-90 mmHg, compared with a MAP maintained at a minimum of 60 mmHg.
MAP is controlled in both groups using continuous infusion of phenylephrine. Phenylephrine is used as a tool in order to assess the effect of MAP on the cerebral circulation. In both groups, central blood volume is optimized by infusion of lactated Ringer´s solution using a goal directed fluid therapy following induction of anaesthesia and before commencement of phenylephrine infusion.
Trial size: The investigators will include 40 participants (2 x 20) in order to detect or reject a 20% difference in middle cerebral artery velocity with a type I error risk of 5% and a type II error risk of 20% (power at 80%). Interim analysis will be conducted after inclusion of 20 patients (2 x 10). Excluded patients will be replaced.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing one of the following vascular surgical interventions in general anesthesia: Infra-inguinal bypass, femoro-femoral cross-over bypass or iliofemoral bypass surgery.
- •Age > 18 years. Informed consent
排除标准
- •Use of monoamine oxidase inhibitors
- •Allergy to phenylephrine
- •Patients that cannot cooperate during examination
- •Dementia defined as Mini-Mental State Examination < 24
- •Anesthesia within the last 30 days
- •Alcohol consumption at or above 420 grams per week
- •Lack of fluency in written and spoken Danish
- •Severe hearing and vision impairment
- •Neurological disease
研究组 & 干预措施
MAP maintained at 80 mmHg
During anesthesia MAP is maintained at 80 - 90 mmHg MAP using continuous infusion of phenylephrine.
干预措施: MAP maintained at 80 mmHg (Other)
MAP maintained at 60 mmHg
During anesthesia MAP is maintained at minimum of 60 mmHg using continuous infusion of phenylephrine.
干预措施: MAP maintained at 60 mmHg (Other)
结局指标
主要结局
Middle cerebral artery blood velocity
时间窗: During surgery
Middle cerebral artery blood velocity measured in \[cm/s\] assessed by transcranial Doppler. Changes in middle cerebral artery blood velocity reflects changes in cerebral blood flow.
次要结局
- Change in serum neuron-specific enolase as compared between subjects in the control- and intervention groups(Blood is sampled 10 min prior to induction of anesthesia and at the end of surgery)
- Stroke volume as compared between subjects in the control- and intervention groups(During surgery)
- Change in serum S100B as compared between subjects in the control- and intervention groups(Blood is sampled 10 min prior to induction of anesthesia and at the end of surgery)
- Regional cerebral oxygenation as compared between subjects in the control- and intervention groups(During surgery)
- Cardiac output as compared between subjects in the control- and intervention groups(During surgery)
研究者
Niels Damkjær Olesen
MD
Rigshospitalet, Denmark