Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-27 @ 8:25 AM
Study NCT ID:
NCT04619160
Status:
UNKNOWN
Last Update Posted:
2020-11-06
First Post:
2020-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Propofol Versus Sevoflurane During FESS
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'The surgeon and participant are blinded for randomization. The anesthesiologist is unblinded.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-02', 'studyFirstSubmitDate': '2020-10-28', 'studyFirstSubmitQcDate': '2020-11-02', 'lastUpdatePostDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Boezaart surgical grading scale', 'timeFrame': 'during surgery', 'description': 'Evaluation of surgical conditions by determination of the validated Boezaart surgical grading scale. Score 0 (no bleeding) to 5 (severe bleeding) The scale will be determined by the operating surgeon and 3 independent surgeons based on an endoscopic video recording.'}], 'secondaryOutcomes': [{'measure': 'Surgery duration', 'timeFrame': 'Immediately after surgery', 'description': 'Length of surgery in minutes'}, {'measure': 'Arterial blood pressure', 'timeFrame': 'During surgery', 'description': 'Mean Arterial Blood Pressure (in mmHg)'}, {'measure': 'Length of stay on the PACU', 'timeFrame': 'From arrival on the PACU until achievement of the PACU discharge criteria', 'description': 'number of minutes on the PACU'}, {'measure': 'Postoperative pain scores', 'timeFrame': 'in the first 48 hours after surgery', 'description': 'Postoperative Visual Analogue scores'}, {'measure': 'PONV scores', 'timeFrame': 'In the first 48 hours after surgery', 'description': 'Postoperative nausea/vomiting scores'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['haemodynamic', 'peripheral blood flow', 'FESS'], 'conditions': ['Sinus Infection Chronic']}, 'descriptionModule': {'briefSummary': 'Good surgical conditions are crucial for an optimal surgery result and safe procedure. Minimal blood loss in the surgical field is one of the most important conditions to maintain a good visualization, especially in surgeries with a small surgical field such as a FESS (functional endoscopic sinus surgery). The perioperative blood loss is determined by the main arterial and venous pressure, the local pressure and the capillary vascular filling pressure.\n\nIt has been proposed that propofol is a venodilator, which increases the blood flow, but decreases the capillary pressure. On the contrary, sevoflurane might act mainly on the arterioles, which causes an increase in the capillary pressure. In a previous study it has been demonstrated that despite blood pressure maintenance, propofol causes less bleeding during spinal surgery than sevoflurane.\n\nThe main aim of this study was to compare both anaesthetics on the perioperative bleeding and haemodynamics during FESS. Secondary, the postoperative nausea, vomiting, pain scores, surgery duration and length of stay at the post-anesthesia care unit will be evaluated.', 'detailedDescription': '2 X 30 patients which are planned for FESS surgery are randomized in a sevoflurane group or propofol group.\n\nAll patients will be induced with propofol (target-controlled infusion (TCI) 4 µg/mL) and remifentanil (TCI 4 ng/mL) and receive a multimodal intravenous analgesia.\n\nPatients in the propofol group will receive further intravenous propofol until a bispectral index (BIS) value of 50 is reached.\n\nThe intravenous drip of propofol will be stopped after induction in the sevoflurane group and patients will receive sevoflurane as inhalation anaesthetic (1 MAC) until a BIS-value of 50. The surgeon will be blinded for patient allocation.\n\nThe surgical conditions will be graded postoperatively by the surgeon who performed the operation using the validated Boezaart grading scale. The endoscopic images will be evaluated in addition by 3 blinded surgeons using this same scale.\n\nBesides the surgical conditions, haemodynamic parameters, nausea and vomiting scores (PONV), Visual Analogue Score (VAS), surgery duration, length of stay at the post-anesthesia care unit and postoperative analgesia and anti-emetics are registered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient planned for FESS surgery\n\nExclusion Criteria:\n\n* patients which receive anticoagulants\n* patients which have coagulation disorders\n* patients with high bleeding risk\n* patients with arterial hypertension\n* other decided by surgeon'}, 'identificationModule': {'nctId': 'NCT04619160', 'briefTitle': 'Propofol Versus Sevoflurane During FESS', 'organization': {'class': 'OTHER', 'fullName': 'Algemeen Ziekenhuis Maria Middelares'}, 'officialTitle': 'Influence of Propofol Versus Sevoflurane on Surgical Conditions During Functional Endoscopic Sinus Surgery', 'orgStudyIdInfo': {'id': 'MMS.2019.043'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'propofol', 'interventionNames': ['Drug: Propofol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sevoflurane', 'interventionNames': ['Drug: Sevoflurane']}], 'interventions': [{'name': 'Propofol', 'type': 'DRUG', 'description': 'TCI 4 µg/mL start until BIS-value of 50', 'armGroupLabels': ['propofol']}, {'name': 'Sevoflurane', 'type': 'DRUG', 'description': 'start 1 MAC, until BIS-value of 50', 'armGroupLabels': ['sevoflurane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'state': 'Oost-Vlaanderen', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Alain F Kalmar, MD, PhD', 'role': 'CONTACT', 'email': 'alainkalmar@gmail.com', 'phone': '+32 9 246 1729'}], 'facility': 'General Hospital Maria Middelares', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'centralContacts': [{'name': 'Alain F Kalmar, MD, PhD, MSc', 'role': 'CONTACT', 'email': 'alainkalmar@gmail.com', 'phone': '+32 246 17 29'}, {'name': 'Nicky Van Der Vekens, DVM, PhD', 'role': 'CONTACT', 'email': 'nicky.vandervekens@azmmsj.be', 'phone': '+32 246 1709'}], 'overallOfficials': [{'name': 'Alain F Kalmar, MD, PhD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maria Middelares Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Algemeen Ziekenhuis Maria Middelares', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Anesthesist', 'investigatorFullName': 'Dr. Alain Kalmar, MD, PhD', 'investigatorAffiliation': 'Algemeen Ziekenhuis Maria Middelares'}}}}