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The Effect of Epidural Anesthesia on the Optic Nerve Sheath Diameter in Preeclampsia

The Effect of Epidural Anesthesia on the Optic Nerve Sheath Diameter in Preeclampsia: A Prospective Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04095832
Acronym
ONSD
Enrollment
22
Registered
2019-09-19
Start date
2020-04-14
Completion date
2023-05-19
Last updated
2023-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia

Brief summary

This study aims to assess the effect of epidural anesthesia on the optic nerve sheath diameter in parturients with preeclampsia.

Detailed description

This prospective observational study will be performed in parturients, either with or without preeclampsia, who scheduled to undergo elective cesarean delivery under epidural anesthesia. Epidural anesthesia will be done according to the standard technique. Optic nerve sheath diameter (ONSD) will be measured before and after the epidural injection of anesthetic solutions using ultrasonography. The investigators will assess whether epidural anesthesia has effect on optic nerve sheath diameter of pregnant women, and the investigators will also compare ONSD between healthy parturients and parturients with preeclampsia. The investigators will evaluate the relationship between ONSD and disease severity of preeclampsia.

Interventions

PROCEDUREEpidural anesthesia

Epidural anesthesia using standardized technique

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients scheduled to undergo planned cesarean section under epidural anesthesia if they have a singleton pregnancy, complicated by severe preeclampsia. Severe preeclampsia was defined using the American College of Obstetricians and Gynecologist Task Force on Hypertension in Pregnancy recommendations * Controls will be healthy pregnant women at term (\>37 weeks), with a singleton pregnancy, no signs or symptoms of preeclampsia and no intrauterine fetal growth restriction, who are planned to undergo elective cesarean delivery under epidural anesthesia

Exclusion criteria

* Contraindication to epidural anesthesia * Morbid cardiovascular disease * Cerebrovascular disease * Known fetal anomaly * Any signs of onset of labor * Body weight \< 40 kg or body weight \> 100 kg * Height \< 140cm or height \> 190cm * eye disease * infection or trauma near the eyes * abnormality of intracranial pressure due to Intracranial pathology

Design outcomes

Primary

MeasureTime frameDescription
Optic nerve sheath diameter (ONSD) after epidural anesthesia3 minutes after the completion of epidural injection of the anesthetic solutionsmeasured by transocular ultrasonography

Secondary

MeasureTime frameDescription
Blood pressureon delivery dayblood pressure in mmHg
Proteinuriaduring the admission periodThe presence of Proteinuria during the admission period
Epigastric painduring the admission periodThe occurrence of epigastric pain during the admission period
Headacheduring the admission periodThe occurrence of Headache during the admission period
Visual disturbancesduring the admission periodThe occurrence of Visual disturbances during the admission period
Oliguriaduring the admission periodThe occurrence of Oliguria during the admission period
eclampsiaduring the admission periodThe occurrence of seizure during the admission period
intracranial hemorrhageduring the admission periodThe occurrence of intracranial hemorrhage during the admission period
Serum creatinineduring the admission periodSerum creatinine concentration
Optic nerve sheath diameter (ONSD)before epidural anesthesia, 10, 20 minutes after the completion of epidural injection of the anesthetic solutions, 10 minutes after delivery of fetus, at the end of surgery.measured by transocular ultrasonography
Platelet countduring the admission periodPlatelet count measured during the admission period
ASTduring the admission periodAST measured during the admission period
Apgar Score of fetusat 1 min, 5 minApgar Score of delivered fetus
Umbilical arterial pHimmediately after deliverypH in mmol/L, Umbilical arterial blood gas analysis
ALTduring the admission periodALT measured during the admission period
Umbilical arterial base excessimmediately after deliverybase excess in mmol/L, Umbilical arterial blood gas analysis
Umbilical arterial PO2immediately after deliveryPO2 in mmHg, Umbilical arterial blood gas analysis
Umbilical arterial PCO2immediately after deliveryPCO2 in mmHg, Umbilical arterial blood gas analysis
Serum albuminduring the admission periodSerum albumin concentration

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026