Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-01-08 @ 4:39 PM
Study NCT ID:
NCT01641302
Status:
COMPLETED
Last Update Posted:
2013-08-07
First Post:
2012-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Pneumoperitoneum and Trendelenburg Position on Intracranial Pressure: Ultrasonographic Measurement of Optic Nerve Sheath Diameter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-05', 'studyFirstSubmitDate': '2012-06-28', 'studyFirstSubmitQcDate': '2012-07-13', 'lastUpdatePostDateStruct': {'date': '2013-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ultrasonographic measurement of optic nerve sheath diameter', 'timeFrame': 'before anesthesia induction, 10 minutes after anesthesia induction, 30 minutes after steep trendelenburg position and pneumoperitoneum, and 10 minutes after supine position, CO2 desufflation.', 'description': 'A thick layer of gel is applied on the upper closed eyelid. The linear 13- to 6-MHz ultrasound probe is then placed in the gel, without exerting pressure on the eye. Two measurements are taken for each optic nerve: one in the transverse plane, with the probe being horizontal, and one in the sagittal plane, with the probe being vertical. The final ONSD is the mean of these measurements.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Robot-assisted Laparoscopic Prostatectomy Under General Anesthesia']}, 'descriptionModule': {'briefSummary': 'The steep Trendelenburg position and pneumoperitoneum during laparoscopic surgery have the potential to cause an increase of intracranial pressure (ICP). Previous studies have proposed that ultrasonographic measurements of the optic nerve sheath diameter (ONSD) correlate with signs of increased ICP. Therefore, this study is aim to confirm the increased ICP by ultrasonographic measurement of ONSD during laparoscopic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing robot-assisted laparoscopic prostatectomy under general anesthesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (20-90 years of age) scheduled for undergoing robot-assisted laparoscopic prostatectomy undergoing general anesthesia\n\nExclusion Criteria:\n\n* Patients with previous history of neurologic disease, carotid disease, transient ischemic attack, ocular disease and ocular surgery'}, 'identificationModule': {'nctId': 'NCT01641302', 'briefTitle': 'The Effect of Pneumoperitoneum and Trendelenburg Position on Intracranial Pressure: Ultrasonographic Measurement of Optic Nerve Sheath Diameter', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2012-0287.'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing robot-assisted laparoscopic prostatectomy', 'description': 'Patients undergoing robot-assisted laparoscopic prostatectomy under general anesthesia'}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Associate Professor Department of Anesthesiology and Pain Medicine,', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}