Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2026-04-05 @ 2:38 AM
Study NCT ID:
NCT03772106
Status:
COMPLETED
Last Update Posted:
2018-12-11
First Post:
2018-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Sevoflurane and Propofol on Hepato-splanchnic Pressure and Flow During Hepatobiliary Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000077149', 'term': 'Sevoflurane'}], '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': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-10', 'studyFirstSubmitDate': '2018-12-04', 'studyFirstSubmitQcDate': '2018-12-10', 'lastUpdatePostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in blood flow in hepatic artery and main portal vein', 'timeFrame': 'From randomization until the end of the whipple surgery', 'description': 'flow/pressure measurements with echo probe and needle'}], 'secondaryOutcomes': [{'measure': 'need of inotropic and/or vasopressor support', 'timeFrame': 'From start anesthesia until end of anesthesia', 'description': 'total dose of inotropic and vasopressor medication that were used during surgery'}, {'measure': 'amount of blood loss', 'timeFrame': 'From start of surgery until end of surgery', 'description': 'amount of blood loss at end of surgery'}, {'measure': 'amount of colloids given during surgery', 'timeFrame': 'From start of surgery until end of surgery', 'description': 'total amount of colloids given during surgery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hepato-splanchnic blood flow'], 'conditions': ['General Anesthesia']}, 'referencesModule': {'references': [{'pmid': '32962657', 'type': 'DERIVED', 'citation': 'van Limmen J, Wyffels P, Berrevoet F, Vanlander A, Coeman L, Wouters P, De Hert S, De Baerdemaeker L. Effects of propofol and sevoflurane on hepatic blood flow: a randomized controlled trial. BMC Anesthesiol. 2020 Sep 22;20(1):241. doi: 10.1186/s12871-020-01150-3.'}]}, 'descriptionModule': {'briefSummary': 'Blood loss in hepatobiliary surgery is correlated with an increase in postoperative complications (e.g. transfusion related lung injury and tumor recurrence) and reduced longterm survival. To reduce morbidity and mortality in hepatobiliary surgery, modulation of the hepato-splanchnic blood flow and pressure is used. In liver surgery pharmacological modulations are widely used to prevent blood loss. For pharmacological modulation central venous pressure is commonly used to reduce the pressure in the inferior vena cava, however little is known about pharmacological effect on blood flow in the hepatic artery and portal vein. The modulation of the hepato-splanchnic blood flow can also play an important role, not only for prevention of blood loss but also for survival of the organs (e.g. ischemic injury due to low flow).\n\nVolatile anesthetics induce a dose-dependent reduction of the hepato-splanchninc blood flow. Propofol however, increases hepatic blood flow when compared with volatile anesthetics. Pharmacological modulation of hepato-splanchnic bloodflow with anesthetics such as sevoflurane or propofol can play an important role in modulation of ischemia/reperfusion injury and survival of organs.\n\nThe aim of the study is to determine and to compare the effect of sevoflurane versus propofol on hepatosplanchnic pressure and hepato-splanchnic blood flow during hepatobiliary surgery.', 'detailedDescription': 'All patients receive standardized anesthesia care for hepato-biliary surgery according to the existing anesthesia protocol. The type of anaesthesia will be randomized : propolipid (TIV) or sevorane(inhalation).\n\nAt designated times, hemodynamic variables will be recorded.\n\nThese will include:\n\n* HF (/min)\n* CVP (mmHg),\n* MAP (mmHg)\n* CI (L/min.m2)\n* PPV (pulse pressure variation). Hemodynamic measurement will be done using PiCCO catheter.\n\nThe hemodynamic measurements will be compared and related to hepato-splanchnic blood flow and pressure measurements performed by the surgeon:\n\n* Flow v. porta\n* Flow art. hepatica\n* Pressure v. porta\n* Pressure v. cava The flow measurements will be done using ultrasound transit time flow measurements TTFM (Medi-Stim AS, Oslo, Norway).\n\nAt the same time pressure measurements will be obtained in portal vein and caval vein using a 25-gauge needle which is directly placed in the vein. Both flow and pressure will be simultaneously recorded (VeriQ 4122, Medi-Stim AS, Oslo, Norway). Both measurements will be done during apnea to minimize the effect of ventilation on pressure \\& flow. Flow values will be expressed in ml per minute, pressure values will be expressed in mmHg.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult ≥ 18 years (Female or Male)\n* ASA I - II - III\n* Able to comprehend, sign and date the written informed consent document to participate in the clinical trial.\n* Scheduled for hepato-biliary surgery.\n\nExclusion Criteria:\n\n* Allergy for the medication\n* Renal insufficiency (SCr \\> 2 mg/dl)\n* Severe heart failure (EF \\< 25%)\n* Hemodynamic instable patients\n* Arterial fibrillation\n* Sepsis\n* BMI \\> 40\n* Severe coagulopathy (INR \\> 2)\n* Thrombocytopenia (\\< 80 x 10³ /µL)\n* History of severe postoperative nausea \\& vomiting'}, 'identificationModule': {'nctId': 'NCT03772106', 'briefTitle': 'Effect of Sevoflurane and Propofol on Hepato-splanchnic Pressure and Flow During Hepatobiliary Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Effect of Sevoflurane and Propofol on Hepato-splanchnic Pressure and Flow During Hepatobiliary Surgery', 'orgStudyIdInfo': {'id': '2017/0164'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group P', 'description': 'Group P : Propolipid 1% dose : variable to keep BIS between 40 and 60', 'interventionNames': ['Drug: Propofol Fresenius']}, {'type': 'EXPERIMENTAL', 'label': 'Group S', 'description': 'Group S : Sevoflurane dose : variable to keep BIS between 40 and 60', 'interventionNames': ['Drug: sevorane']}], 'interventions': [{'name': 'Propofol Fresenius', 'type': 'DRUG', 'description': 'Propolipid 1% : IV', 'armGroupLabels': ['Group P']}, {'name': 'sevorane', 'type': 'DRUG', 'description': 'sevorane Quick fill (sevoflurane) : inhalation', 'armGroupLabels': ['Group S']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'state': 'Oost-Vlaanderen', 'country': 'Belgium', 'facility': 'University Hospital Ghent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Jurgten Van Limmen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UZ Ghent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}