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NCT Number: NCT04095832

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

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

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Key information

Age range

19 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

epidural anesthesia

Procedure

Epidural anesthesia using standardized technique

Primary outcomes

  1. Optic nerve sheath diameter (ONSD) after epidural anesthesia

    Time frame: 3 minutes after the completion of epidural injection of the anesthetic solutions

    measured by transocular ultrasonography

Secondary outcomes

  1. Optic nerve sheath diameter (ONSD)

    Time frame: 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

  2. Blood pressure

    Time frame: on delivery day

    blood pressure in mmHg

  3. Proteinuria

    Time frame: during the admission period

    The presence of Proteinuria during the admission period

  4. Epigastric pain

    Time frame: during the admission period

    The occurrence of epigastric pain during the admission period

  5. Headache

    Time frame: during the admission period

    The occurrence of Headache during the admission period

  6. Visual disturbances

    Time frame: during the admission period

    The occurrence of Visual disturbances during the admission period

  7. Oliguria

    Time frame: during the admission period

    The occurrence of Oliguria during the admission period

  8. eclampsia

    Time frame: during the admission period

    The occurrence of seizure during the admission period

  9. intracranial hemorrhage

    Time frame: during the admission period

    The occurrence of intracranial hemorrhage during the admission period

  10. Serum creatinine

    Time frame: during the admission period

    Serum creatinine concentration

  11. Serum albumin

    Time frame: during the admission period

    Serum albumin concentration

  12. Platelet count

    Time frame: during the admission period

    Platelet count measured during the admission period

  13. AST

    Time frame: during the admission period

    AST measured during the admission period

  14. Apgar Score of fetus

    Time frame: at 1 min, 5 min

    Apgar Score of delivered fetus

  15. Umbilical arterial pH

    Time frame: immediately after delivery

    pH in mmol/L, Umbilical arterial blood gas analysis

  16. ALT

    Time frame: during the admission period

    ALT measured during the admission period

  17. Umbilical arterial base excess

    Time frame: immediately after delivery

    base excess in mmol/L, Umbilical arterial blood gas analysis

  18. Umbilical arterial PO2

    Time frame: immediately after delivery

    PO2 in mmHg, Umbilical arterial blood gas analysis

  19. Umbilical arterial PCO2

    Time frame: immediately after delivery

    PCO2 in mmHg, Umbilical arterial blood gas analysis

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Acronym: ONSD

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 19, 2019
Registry last updated
May 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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