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

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

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

Study Overview

• Status: Completed
• Conditions: Preeclampsia
• Intervention / Treatment: Procedure: Epidural anesthesia

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.

• Study Type: Observational
• Enrollment (Actual): 22

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

We plans to include 11 preeclamptic patients and 11 healthy pregnant women.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Parturients with preeclampsia; Parturients who were diagnosed with preeclampsia	Procedure: Epidural anesthesia; Epidural anesthesia using standardized technique
Healthy parturients; Healthy full-term parturients	Procedure: Epidural anesthesia; Epidural anesthesia using standardized technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optic nerve sheath diameter (ONSD) after epidural anesthesia	measured by transocular ultrasonography	3 minutes after the completion of epidural injection of the anesthetic solutions

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optic nerve sheath diameter (ONSD)	measured by transocular ultrasonography	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.
Blood pressure	blood pressure in mmHg	on delivery day
Proteinuria	The presence of Proteinuria during the admission period	during the admission period
Epigastric pain	The occurrence of epigastric pain during the admission period	during the admission period
Headache	The occurrence of Headache during the admission period	during the admission period
Visual disturbances	The occurrence of Visual disturbances during the admission period	during the admission period
Oliguria	The occurrence of Oliguria during the admission period	during the admission period
eclampsia	The occurrence of seizure during the admission period	during the admission period
intracranial hemorrhage	The occurrence of intracranial hemorrhage during the admission period	during the admission period
Serum creatinine	Serum creatinine concentration	during the admission period
Serum albumin	Serum albumin concentration	during the admission period
Platelet count	Platelet count measured during the admission period	during the admission period
AST	AST measured during the admission period	during the admission period
Apgar Score of fetus	Apgar Score of delivered fetus	at 1 min, 5 min
Umbilical arterial pH	pH in mmol/L, Umbilical arterial blood gas analysis	immediately after delivery
ALT	ALT measured during the admission period	during the admission period
Umbilical arterial base excess	base excess in mmol/L, Umbilical arterial blood gas analysis	immediately after delivery
Umbilical arterial PO2	PO2 in mmHg, Umbilical arterial blood gas analysis	immediately after delivery
Umbilical arterial PCO2	PCO2 in mmHg, Umbilical arterial blood gas analysis	immediately after delivery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Jin-Tae Kim, MD, PhD, Seoul National University Hospital

Publications and helpful links

General Publications

• Brzan Simenc G, Ambrozic J, Prokselj K, Tul N, Cvijic M, Mirkovic T, Lucovnik M. Ocular ultrasonography for diagnosing increased intracranial pressure in patients with severe preeclampsia. Int J Obstet Anesth. 2018 Nov;36:49-55. doi: 10.1016/j.ijoa.2018.06.005. Epub 2018 Jul 4.
• Ortner CM, Krishnamoorthy V, Neethling E, Flint M, Swanevelder JL, Lombard C, Fawcus S, Dyer RA. Point-of-Care Ultrasound Abnormalities in Late-Onset Severe Preeclampsia: Prevalence and Association With Serum Albumin and Brain Natriuretic Peptide. Anesth Analg. 2019 Jun;128(6):1208-1216. doi: 10.1213/ANE.0000000000003759.

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2020
• Primary Completion (Actual): May 9, 2023
• Study Completion (Actual): May 19, 2023

Study Registration Dates

• First Submitted: September 16, 2019
• First Submitted That Met QC Criteria: September 18, 2019
• First Posted (Actual): September 19, 2019

Study Record Updates

• Last Update Posted (Actual): May 30, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pre-Eclampsia; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 1908-051-1055

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No