Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-01-20 @ 8:15 PM
Study NCT ID:
NCT04095832
Status:
COMPLETED
Last Update Posted:
2023-05-30
First Post:
2019-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Epidural Anesthesia on the Optic Nerve Sheath Diameter in Preeclampsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000767', 'term': 'Anesthesia, Epidural'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-25', 'studyFirstSubmitDate': '2019-09-16', 'studyFirstSubmitQcDate': '2019-09-18', 'lastUpdatePostDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Optic nerve sheath diameter (ONSD) after epidural anesthesia', 'timeFrame': '3 minutes after the completion of epidural injection of the anesthetic solutions', 'description': 'measured by transocular ultrasonography'}], 'secondaryOutcomes': [{'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.', 'description': 'measured by transocular ultrasonography'}, {'measure': 'Blood pressure', 'timeFrame': 'on delivery day', 'description': 'blood pressure in mmHg'}, {'measure': 'Proteinuria', 'timeFrame': 'during the admission period', 'description': 'The presence of Proteinuria during the admission period'}, {'measure': 'Epigastric pain', 'timeFrame': 'during the admission period', 'description': 'The occurrence of epigastric pain during the admission period'}, {'measure': 'Headache', 'timeFrame': 'during the admission period', 'description': 'The occurrence of Headache during the admission period'}, {'measure': 'Visual disturbances', 'timeFrame': 'during the admission period', 'description': 'The occurrence of Visual disturbances during the admission period'}, {'measure': 'Oliguria', 'timeFrame': 'during the admission period', 'description': 'The occurrence of Oliguria during the admission period'}, {'measure': 'eclampsia', 'timeFrame': 'during the admission period', 'description': 'The occurrence of seizure during the admission period'}, {'measure': 'intracranial hemorrhage', 'timeFrame': 'during the admission period', 'description': 'The occurrence of intracranial hemorrhage during the admission period'}, {'measure': 'Serum creatinine', 'timeFrame': 'during the admission period', 'description': 'Serum creatinine concentration'}, {'measure': 'Serum albumin', 'timeFrame': 'during the admission period', 'description': 'Serum albumin concentration'}, {'measure': 'Platelet count', 'timeFrame': 'during the admission period', 'description': 'Platelet count measured during the admission period'}, {'measure': 'AST', 'timeFrame': 'during the admission period', 'description': 'AST measured during the admission period'}, {'measure': 'Apgar Score of fetus', 'timeFrame': 'at 1 min, 5 min', 'description': 'Apgar Score of delivered fetus'}, {'measure': 'Umbilical arterial pH', 'timeFrame': 'immediately after delivery', 'description': 'pH in mmol/L, Umbilical arterial blood gas analysis'}, {'measure': 'ALT', 'timeFrame': 'during the admission period', 'description': 'ALT measured during the admission period'}, {'measure': 'Umbilical arterial base excess', 'timeFrame': 'immediately after delivery', 'description': 'base excess in mmol/L, Umbilical arterial blood gas analysis'}, {'measure': 'Umbilical arterial PO2', 'timeFrame': 'immediately after delivery', 'description': 'PO2 in mmHg, Umbilical arterial blood gas analysis'}, {'measure': 'Umbilical arterial PCO2', 'timeFrame': 'immediately after delivery', 'description': 'PCO2 in mmHg, Umbilical arterial blood gas analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preeclampsia']}, 'referencesModule': {'references': [{'pmid': '30057149', 'type': 'BACKGROUND', '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.'}, {'pmid': '31094790', 'type': 'BACKGROUND', '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.'}, {'pmid': '38950931', 'type': 'DERIVED', 'citation': 'Park SK, Kim H, Kim Y, Jang YE, Kim JT. Effect of epidural anesthesia on the optic nerve sheath diameter in patients with pre-eclampsia: a prospective observational study. Reg Anesth Pain Med. 2025 Oct 6;50(10):828-834. doi: 10.1136/rapm-2024-105444.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to assess the effect of epidural anesthesia on the optic nerve sheath diameter in parturients with preeclampsia.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We plans to include 11 preeclamptic patients and 11 healthy pregnant women.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled to undergo planned cesarean section under epidural anesthesia if they have a singleton pregnancy, complicated by severe preeclampsia.\n\nSevere preeclampsia was defined using the American College of Obstetricians and Gynecologist Task Force on Hypertension in Pregnancy recommendations\n\n* 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\n\nExclusion Criteria:\n\n* Contraindication to epidural anesthesia\n* Morbid cardiovascular disease\n* Cerebrovascular disease\n* Known fetal anomaly\n* Any signs of onset of labor\n* Body weight \\< 40 kg or body weight \\> 100 kg\n* Height \\< 140cm or height \\> 190cm\n* eye disease\n* infection or trauma near the eyes\n* abnormality of intracranial pressure due to Intracranial pathology'}, 'identificationModule': {'nctId': 'NCT04095832', 'acronym': 'ONSD', 'briefTitle': 'The Effect of Epidural Anesthesia on the Optic Nerve Sheath Diameter in Preeclampsia', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Effect of Epidural Anesthesia on the Optic Nerve Sheath Diameter in Preeclampsia: A Prospective Observational Study', 'orgStudyIdInfo': {'id': '1908-051-1055'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Parturients with preeclampsia', 'description': 'Parturients who were diagnosed with preeclampsia', 'interventionNames': ['Procedure: Epidural anesthesia']}, {'label': 'Healthy parturients', 'description': 'Healthy full-term parturients', 'interventionNames': ['Procedure: Epidural anesthesia']}], 'interventions': [{'name': 'Epidural anesthesia', 'type': 'PROCEDURE', 'description': 'Epidural anesthesia using standardized technique', 'armGroupLabels': ['Healthy parturients', 'Parturients with preeclampsia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jin-Tae Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jin-Tae Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}