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

Preeclampsia Clinical Trial

— ONSD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04095832
• Other study ID #: 1908-051-1055
• Status: Completed
• Start date: April 14, 2020
• Est. completion date: May 19, 2023

Study information

• Verified date: May 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 19, 2023
• Est. primary completion date: May 9, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Procedure:
• Epidural anesthesia
Epidural anesthesia using standardized technique

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Blood pressure	blood pressure in mmHg	on delivery day
Secondary	Proteinuria	The presence of Proteinuria during the admission period	during the admission period
Secondary	Epigastric pain	The occurrence of epigastric pain during the admission period	during the admission period
Secondary	Headache	The occurrence of Headache during the admission period	during the admission period
Secondary	Visual disturbances	The occurrence of Visual disturbances during the admission period	during the admission period
Secondary	Oliguria	The occurrence of Oliguria during the admission period	during the admission period
Secondary	eclampsia	The occurrence of seizure during the admission period	during the admission period
Secondary	intracranial hemorrhage	The occurrence of intracranial hemorrhage during the admission period	during the admission period
Secondary	Serum creatinine	Serum creatinine concentration	during the admission period
Secondary	Serum albumin	Serum albumin concentration	during the admission period
Secondary	Platelet count	Platelet count measured during the admission period	during the admission period
Secondary	AST	AST measured during the admission period	during the admission period
Secondary	Apgar Score of fetus	Apgar Score of delivered fetus	at 1 min, 5 min
Secondary	Umbilical arterial pH	pH in mmol/L, Umbilical arterial blood gas analysis	immediately after delivery
Secondary	ALT	ALT measured during the admission period	during the admission period
Secondary	Umbilical arterial base excess	base excess in mmol/L, Umbilical arterial blood gas analysis	immediately after delivery
Secondary	Umbilical arterial PO2	PO2 in mmHg, Umbilical arterial blood gas analysis	immediately after delivery
Secondary	Umbilical arterial PCO2	PCO2 in mmHg, Umbilical arterial blood gas analysis	immediately after delivery