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Status unknownNCT03917342Updated Apr 17, 2019

Electroencephalographic Effects of Spinal Anaesthesia During Caesarean Delivery in Preeclampsia

An interventional study of EEG measure in Pre-Eclampsia and Effects of; Anesthesia, Spinal and Epidural, in Pregnancy, sponsored by Insel Gruppe AG, University Hospital Bern. Status unknown at 1 site in Switzerland. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-17.

Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Apr 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
Female
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Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Pre-Eclampsia
  • Effects of; Anesthesia, Spinal and Epidural, in Pregnancy
03

In context

Pre-Eclampsia

882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.

This study's planned enrollment of 45 is below the median of 110 across 468 interventional studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.
  • Group B:

    • 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.
  • Group C:

    • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Active comparator
    Control Group

    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

    Device: EEG measure

  • Active comparator
    Healthy parturients

    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

    Device: EEG measure

  • Active comparator
    Preeclamptic parturients

    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

    Device: EEG measure

Interventions

  • DeviceEEG measure

    Frontal 3-derivation EEG measure under different conditions in pregnancy (healthy vs preeclampsia) and baseline non-pregnant women

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What researchers measure

Primary outcomes

  1. Spectral analysis through fast Fourier transformation

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

    Time frame: Baseline, one minute and 60 minutes, 5 minutes for each measure

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

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

    Time frame: Baseline, one minute and 60 minutes, 5 minutes for each measure

07

Study locations

1 site
  • Bern University Hospital
    Bern, 3010, Switzerland
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03917342
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
National Council of Scientific and Technical Research, Argentina, University of Cape Town
Responsible party
Sponsor
First posted
Apr 17, 2019
Start date
May 1, 2019 (estimated)
Primary completion
Dec 31, 2019 (estimated)
Completion
Dec 31, 2020 (estimated)
Last update
Apr 17, 2019

Study contacts

Pascal H Vuilleumier, MD
Contact
pascal.vuilleumier@insel.ch
+41 31 632 32 84
Heiko Kaiser, MD
Contact
heiko.kaiser@insel.ch
+41 31 632 21 11
Heiko Kaiser, MD
study chair · Bern University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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