Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-04-13 @ 2:01 PM
Study NCT ID:
NCT02003768
Status:
WITHDRAWN
Last Update Posted:
2014-07-15
First Post:
2013-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Pnemoperitoneum on Intracranial Pressure and Cerebral Oxygenation During Laparoscopic Surgery According to Anesthesia Agents: Propofol Based Total Intravenous Anesthesia vs Desflurane Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['South Korea']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011027', 'term': 'Pneumoperitoneum'}], 'ancestors': [{'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000077335', 'term': 'Desflurane'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005019', 'term': 'Ethyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-07-13', 'studyFirstSubmitDate': '2013-12-02', 'studyFirstSubmitQcDate': '2013-12-05', 'lastUpdatePostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the ultrasonographic measurement of optic nerve sheath diameter', 'timeFrame': 'baseline', 'description': 'optic nerve sheath diameter measured by ultrasonography'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pneumoperitoneum', 'optic nerve sheath diameter', 'laparoscopy', 'Patients', 'general anesthesia', 'diameter'], 'conditions': ['Optic Nerve Sheath']}, 'referencesModule': {'references': [{'pmid': '22258019', 'type': 'BACKGROUND', 'citation': 'Dubost C, Le Gouez A, Jouffroy V, Roger-Christoph S, Benhamou D, Mercier FJ, Geeraerts T. Optic nerve sheath diameter used as ultrasonographic assessment of the incidence of raised intracranial pressure in preeclampsia: a pilot study. Anesthesiology. 2012 May;116(5):1066-71. doi: 10.1097/ALN.0b013e318246ea1a.'}]}, 'descriptionModule': {'briefSummary': 'The 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. The aim of this study is to compare the effect of pnemoperitoneum on intracranial pressure and cerebral oxygenation during laparoscopic surgery according to anesthesia agents, propofol based total intravenous anesthesia (TIVA group) and desflurane anesthesia (Des group).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (20-80 years of age) scheduled for laparoscopic cholecystectomy 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': 'NCT02003768', 'briefTitle': 'The Effect of Pnemoperitoneum on Intracranial Pressure and Cerebral Oxygenation During Laparoscopic Surgery According to Anesthesia Agents: Propofol Based Total Intravenous Anesthesia vs Desflurane Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2013-0626'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TIVA', 'description': '2% Propofol (Fresofol®), Remifentanil 20mcg/cc (Ultiva®)', 'interventionNames': ['Drug: Propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Des', 'description': 'Desflurane (Suprane®), Remifentanil continuous infusion (20mcg/cc)', 'interventionNames': ['Drug: Desflurane']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'description': '80 patients are randomly allocated into two groups: In TIVA group, propofol based total intravenous anesthesia is used to induce and maintain anesthesia for laparoscopic cholescystectomy.', 'armGroupLabels': ['TIVA']}, {'name': 'Desflurane', 'type': 'DRUG', 'description': '80 patients are randomly allocated into two groups : In Des group, inhalation anesthesia using desflurane is used to induce and maintain anesthesia for laparoscopic cholescystectomy.', 'armGroupLabels': ['Des']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}