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临床试验/NCT03917342
NCT03917342Unknown不适用

Electroencephalographic Effects of Spinal Anaesthesia During Caesarean Delivery in Preeclampsia

Insel Gruppe AG, University Hospital Bern2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2019年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
45
试验地点
2
主要终点
Spectral analysis through fast Fourier transformation

研究概览

简要总结

Neuraxial anesthesia has been associated with delayed brainstem conduction and decreasing afferent sensory transmission, thereby modifying reticulo-thalamo-cortical mechanisms regulating arousal. The state of entropy measured by EEG-monitors has detected sedative effects associated with neuraxial anaesthesia in healthy volunteers, as well as during caesarean delivery. Entropy is a measure of the irregularity or disorder of a brains activity - sedation leading to a decrease of irregularity or disorder in the EEG.The aim of this pilot study is to prospectively assess the effect of spinal anaesthesia in healthy and preeclamptic parturients on brain activity. Decreased epileptiform activity in patients with preeclampsia would suggest that early neuraxial analgesia in labouring preeclamptic patients is beneficial, and may protect against neurological complications.

详细描述

Neuraxial anesthesia has been associated with delayed brainstem conduction and decreasing afferent sensory transmission, thereby modifying reticulo-thalamo-cortical mechanisms regulating arousal. The state of entropy measured by EEG-monitors has detected sedative effects associated with neuraxial anaesthesia in healthy volunteers, as well as during caesarean delivery. Entropy is a measure of the irregularity or disorder of a brains activity - sedation leading to a decrease of irregularity or disorder in the EEG.

The EEG activity in general can be separated into background activity, focal abnormalities, and intermittent and paroxysmal activity.8 Background electrical activity measured with the EEG by surface electrodes, are characterized by their corresponding frequency wave bands, ranging from slow waves (< 1 Hz), Delta (1 - 4 Hz), Theta (4 - 8 Hz), Alpha (8 - 12 Hz), Beta (12 - 30 Hz) and Gamma (> 30 Hz). In healthy volunteers, neuraxial anaesthesia was linked to increased activity - the so-called state of paradoxical excitation. This pattern is similar to the sedative low-dose GABAergic effects known to occur in response to the benzodiazepine midazolam. Epileptic potentials as paroxysmal EEG activity are typically seen with seizures, but they can be a sign of other changes of brain state as well (e.g. (pre)eclampsia or high doses of opioids).

Preeclampsia constitutes a heterogeneous multisystemic disorder defined by the new onset of hypertension and proteinuria after 20 weeks of gestation, affecting 2-8 % of all pregnancies world-wide. In this condition the nervous system is commonly affected, being the cause of significant morbidity and mortality, when seizures occur resembling an epileptic grand-mal convulsion. Significantly, cerebral white matter lesions are described several years after eclamptic episodes. Posterior reversible encephalopathy syndrome (PRES) is also suggested to be a core component of eclampsia. In this condition is associated extensive white matter changes have been detected, using advanced neuroimaging techniques. EEG changes can be detected before clinical signs of PRES are present, and before ischemia leads to irreversible brain damage.14 In preeclampsia EEG changes are also common, consisting of slow waves in the occipital lobe, as well as spike discharges. These EEG changes have been reported in eclampsia and in severe preeclampsia, with some differences between the two conditions. The prevention of eclampsia, which can occur pre-, intra-, or postpartum, is thus a critical management goal. Current literature only describes the use of EEG entropy - reflecting the state of arousal - during neuraxial anaesthesia in parturients. So far no study has assessed the quantitative (qEEG) or paroxysmal EEG changes induced by neuraxial anaesthesia in parturients undergoing caesarean delivery, and such monitoring has particular relevance in a high-risk patient population with preeclampsia.

Aims

The aim of this pilot study is to prospectively assess the effect of spinal anaesthesia in healthy and preeclamptic parturients on brain activity. Decreased epileptiform activity in patients with preeclampsia would suggest that early neuraxial analgesia in labouring preeclamptic patients is beneficial, and may protect against neurological complications.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Group A: Healthy controls, American Society of Anesthesiology (ASA) I or II status, undergoing a hysteroscopic procedure under single shot spinal anaesthesia without intravenous or oral sedation.
  • Healthy ASA I or II status patients undergoing elective caesarean section at term (>37 weeks of gestation) under spinal single shot anaesthesia without intravenous or oral sedation.
  • Singleton pregnancy.
  • ASA I, II or III status patients undergoing elective secondary caesarean section at term (>37 weeks of gestation) under spinal single shot anaesthesia without intravenous or oral sedation
  • Singleton pregnancy
  • Diagnosis of preeclampsia: Systolic blood pressure over140 mmHg or diastolic pressure over 90 mmHg and
  • Proteinuria over 0.3 grams in a 24-hour urine or protein: creatinine ratio superior to 0.3 or signs of end-organ dysfunction (platelet count < 100,000 µL, serum creatinine >110 mg/L, or doubling of the serum creatinine, elevated serum transaminases to twice normal concentration)

排除标准

  • Patient refusal.
  • Active labour.
  • Eclampsia.
  • Hypertensive crisis as defined by systolic blood pressure over 210 mmHg or diastolic pressure over 120 mmHg.
  • Known epilepsy.
  • Anti-epileptic medication and magnesium sulphate.
  • Reported or admitted medication or substance abuse (street drugs, opiates, benzodiazepines, alcohol).
  • Known neurological condition with previously pathologic diagnostic imaging or EEG.
  • Severe fetal malformations (gastroschisis and omphalocele, tracheo-oesophageal fistula, cerebral malformations in the category of cephalic disorders, pulmonary hypoplasia, congenital heart disease).
  • Established rupture of membranes prior to spinal anaesthesia.
  • Non-German and non-French speaking parturient.
  • Lack of written consent

研究组 & 干预措施

Control Group

Active Comparator

EEG measure in 15 healthy women undergoing elective hysteroscopy under single shot spinal anesthesia. Bupivacaine 10mg (+-2mg) spinal dose with 15 mcg Fentanyl spinal dose

干预措施: EEG measure (Device)

Healthy parturients

Active Comparator

EEG measure in 15 healthy parturients undergoing elective cesarean delivery under single shot spinal anesthesia.Bupivacaine 10mg (+-2mg) spinal dose with 15 mcg Fentanyl spinal dose

干预措施: EEG measure (Device)

Preeclamptic parturients

Active Comparator

EEG measure in 15 parturients with preeclampsia undergoing elective cesarean delivery under single shot spinal anesthesia.Bupivacaine 10mg (+-2mg) spinal dose with 15 mcg Fentanyl spinal dose

干预措施: EEG measure (Device)

结局指标

主要结局

Spectral analysis through fast Fourier transformation

时间窗: Baseline, one minute and 60 minutes, 5 minutes for each measure

Change from baseline EEG, EEG after one and 60 minutes after neuraxial anaesthesia

Spectral analysis of the detection of seizure activity by absolute slope analysis (composite endpoint)

时间窗: Baseline, one minute and 60 minutes, 5 minutes for each measure

Change from baseline EEG, EEG after one and 60 minutes after neuraxial anaesthesia

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 (2)

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