Clinical trial NCT04095832: The Effect of Epidural Anesthesia on the Optic Nerve Sheath Diameter in Preeclampsia
Official title: The Effect of Epidural Anesthesia on the Optic Nerve Sheath Diameter in Preeclampsia: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 22
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We plans to include 11 preeclamptic patients and 11 healthy pregnant women.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Optic nerve sheath diameter (ONSD) after epidural anesthesia
timeFrame: 3 minutes after the completion of epidural injection of the anesthetic solutions
Secondary outcomes:
measure: Optic nerve sheath diameter (ONSD)
timeFrame: 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.
measure: Blood pressure
timeFrame: on delivery day
measure: Proteinuria
timeFrame: during the admission period
measure: Epigastric pain
timeFrame: during the admission period
measure: Headache
timeFrame: during the admission period
measure: Visual disturbances
timeFrame: during the admission period
measure: Oliguria
timeFrame: during the admission period
measure: eclampsia
timeFrame: during the admission period
measure: intracranial hemorrhage
timeFrame: during the admission period
measure: Serum creatinine
timeFrame: during the admission period
measure: Serum albumin
timeFrame: during the admission period
measure: Platelet count
timeFrame: during the admission period
measure: AST
timeFrame: during the admission period
measure: Apgar Score of fetus
timeFrame: at 1 min, 5 min
measure: Umbilical arterial pH
timeFrame: immediately after delivery
measure: ALT
timeFrame: during the admission period
measure: Umbilical arterial base excess
timeFrame: immediately after delivery
measure: Umbilical arterial PO2
timeFrame: immediately after delivery
measure: Umbilical arterial PCO2
timeFrame: immediately after delivery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.