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临床试验/NCT04288869
NCT04288869终止不适用

Change in Brain Perfusion During Induction of General Anesthesia: Relationship Between Transcranial Doppler, Bispectral Index and Cerebral Oximetry : a Prospective Observational Study CERVO2

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2021年1月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
68
试验地点
1
主要终点
Cerebral oxygen saturation

研究概览

简要总结

Arterial hypotension during general anesthesia remains a factor of poor outcomes, increases the risk of myocardial infarction, acute kidney injury and 1-year mortality. Furthermore, arterial hypotension may also decrease cerebral perfusion contributing to worsen neurological outcome. It seems necessary to monitor cerebral perfusion during anesthesia and to define individual dynamic targets of blood pressure. The goal of this study is to evaluate cerebral perfusion change in adult patients with or without cardiovascular risk factors during a standardized propofol-remifentanil anesthesia induction. Cerebral perfusion will be evaluated and compared by simultaneous measurements of cerebral blood flow, cerebral oxygen saturation and neurological function with use of transcranial Doppler (TCD), Near infrared spectroscopy (NIRS) and the Bispectral index (BIS) monitoring, respectively. Those measurements will be also repeated during and after treatment of arterial hypotension episodes in both groups.

详细描述

Main objective: blood pressure target to maintain cerebral perfusion is related to patient's characteristics or comorbidities, it remains uncertain which threshold of blood pressure is to use during general anesthesia in each specific case. Thus, it seems necessary to monitor the cerebral perfusion during anesthesia and to determine the individual dynamic targets of blood pressure. The measure of middle cerebral artery blood flow velocity by transcranial doppler (TCD) is a clinical method to assess cerebral perfusion during general anesthesia and several studies have reported the hemodynamic impact on cerebral blood flow during induction.

Cerebral perfusion can also be approached by near infrared spectroscopy (NIRS) which measures continuously cerebral oxygen saturation. Bispectral index (BIS), which allows a simplified form of continuous electroencephalogram monitoring to assess depth of anesthesia, could also provide the cerebral hypoperfusion assessment quantified by the count of burst suppression ratio (SR). Potentially, those tools need to be combined to assess cerebral perfusion properly.

The goal of this study is to evaluate cerebral perfusion change in adult participants with or without cardiovascular risk factors during a standardized propofol-remifentanil anesthesia induction. Cerebral perfusion will be evaluated and compared using simultaneously the TCD, NIRS and BIS measurements. Those measurements will be also repeated during and after treatment of arterial hypotension episodes in both groups.

Population concerned : the study involves major patients who benefit from intraoperative hemodynamic optimization with norepinephrine (as noradrenaline tartrate) for maintaining blood pressure under general anesthesia during an interventional neuroradiology procedure or orthopedic surgery.

Research Proceedings: all monitoring (TCD, BIS, NIRS) will be collected from the healthy side, contralateral to the interventional side. BIS, NIRS and continuous non-invasive blood pressure measurement will be all connected to the main monitor. For all participants, the data from TCD, NIRS, BIS and the hemodynamic data will be collected over three distinct periods of the interventional procedure : (1) baseline or during preoxygenation at FiO2 of 21% (fraction of inspired oxygen) in awake patients, (2) before Orotracheal Intubation and (3) just after mechanical ventilation.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Major patients (≥ 18 years old)
  • •Eligible for an interventional radiology procedure or orthopedic surgery under general anesthesia.
  • •Patients who expressed their non-opposition to participation in this research

排除标准

  • •Patients under the age of
  • •Patient opposed to participation in the protocol
  • •Pregnant woman
  • •Patient under judicial protection measure
  • •Patient without affiliation to a social security scheme-

研究组 & 干预措施

Interventional radiology or surgery under general anesthesia

Monitoring of patients (mean arterial blood pressure, Transcranial Doppler , bispectral index, near infrared spectroscopy) who benefit from intraoperative hemodynamic optimization with norepinephrine (as noradrenaline tartrate) for maintaining blood pressure under general anaesthesia during the interventional neuroradiology or orthopedic surgery in adults .

干预措施: Continuous monitoring of arterial blood pressure (Other)

Interventional radiology or surgery under general anesthesia

Monitoring of patients (mean arterial blood pressure, Transcranial Doppler , bispectral index, near infrared spectroscopy) who benefit from intraoperative hemodynamic optimization with norepinephrine (as noradrenaline tartrate) for maintaining blood pressure under general anaesthesia during the interventional neuroradiology or orthopedic surgery in adults .

干预措施: Transcranial Doppler (Other)

Interventional radiology or surgery under general anesthesia

Monitoring of patients (mean arterial blood pressure, Transcranial Doppler , bispectral index, near infrared spectroscopy) who benefit from intraoperative hemodynamic optimization with norepinephrine (as noradrenaline tartrate) for maintaining blood pressure under general anaesthesia during the interventional neuroradiology or orthopedic surgery in adults .

干预措施: Bispectral Index (BIS) (Other)

Interventional radiology or surgery under general anesthesia

Monitoring of patients (mean arterial blood pressure, Transcranial Doppler , bispectral index, near infrared spectroscopy) who benefit from intraoperative hemodynamic optimization with norepinephrine (as noradrenaline tartrate) for maintaining blood pressure under general anaesthesia during the interventional neuroradiology or orthopedic surgery in adults .

干预措施: Near-infrared spectroscopy (Other)

结局指标

主要结局

Cerebral oxygen saturation

时间窗: Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day)

For all patients, the cerebral oxygen saturation (SO2; %) will be collected continuously, using Near-infrared spectroscopy, over three distinct periods: 1) baseline or during pre-oxygenation at FiO2 of 21% in awake patients, 2) before orotracheal intubation, and 3) just after mechanical ventilation.

Mean arterial blood pressure

时间窗: Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day)

For all patients, the mean arterial pressure (unit mmHg) will be collected continuously, over three distinct periods: 1) baseline or during pre-oxygenation at FiO2 of 21% in awake patients, 2) before orotracheal intubation, and 3) just after mechanical ventilation

Burst Suppression

时间窗: Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day)

Continuous measurement of burst suppression (BS; %) with use of Bispectral Index (BIS) over three distinct periods: 1) baseline or during pre-oxygenation at FiO2 of 21% in awake patients, 2) before orotracheal intubation, and 3) just after mechanical ventilation.

Cerebral blood flow velocity

时间窗: Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day)

For all patients, CFV (unit cm/s) will be collected continuously, using Transcranial Doppler, over three distinct periods: 1) baseline or during pre-oxygenation at FiO2 of 21% in awake patients, 2) before orotracheal intubation, and 3) just after mechanical ventilation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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