Electroencephalographic Effects of Spinal Anaesthesia During Caesarean Delivery in Preeclampsia

NCT03917342 | Unknown

• 1 other identifier: 20190123
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Spectral analysis through fast Fourier transformation

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

  Baseline, one minute and 60 minutes, 5 minutes for each measure

• 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

  Baseline, one minute and 60 minutes, 5 minutes for each measure

Study Arms (3)

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

Device: EEG measure

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

Device: EEG measure

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

Device: EEG measure

Interventions

EEG measure DEVICE

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

Control Group; Healthy parturients; Preeclamptic parturients

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• National Council of Scientific and Technical Research, Argentina: collaborator
• University of Cape Town: collaborator

Study Sites (1)

Bern University Hospital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Heiko Kaiser, MD

  Bern University Hospital

  STUDY CHAIR

Central Study Contacts

Pascal H Vuilleumier, MD

CONTACT

+41 31 632 32 84; pascal.vuilleumier@insel.ch

Heiko Kaiser, MD

CONTACT

+41 31 632 21 11; heiko.kaiser@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Three groups of subjects studied: A: Control group: 15 healthy women B: 15 Healthy parturients: elective cesarean delivery C: 15 preeclamptic parturients: cesarean delivery

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: April 17, 2019
• Study Start: May 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)