Ignite Creation Date:
2025-12-24 @ 2:01 PM
Ignite Modification Date:
2026-02-22 @ 5:22 PM
Study NCT ID:
NCT06558695
Status:
COMPLETED
Last Update Posted:
2024-08-19
First Post:
2024-08-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stability Comparison of TIVA and Sevoflurane in Prone Spinal Surgery(TIVA:Total Intravenous Anesthesia)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013130', 'term': 'Spinal Stenosis'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077149', 'term': 'Sevoflurane'}], 'ancestors': [{'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants were randomly assigned to one of two groups using a computer-generated list: the Sevoflurane group (Sevo group) and the Total Intravenous Anesthesia group (TIVA group), each comprising 26 patients. The assignment and subsequent anesthesia management were conducted in a double-blinded manner, ensuring that neither the patients nor the clinicians administering the treatments or assessing the outcomes were aware of the group allocations'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This randomized controlled trial involved 52 patients scheduled for lumbar spine surgery under general anesthesia. Participants were randomly allocated to either the TIVA group (n=26) or the sevoflurane group (n=26). Measurements of respiratory mechanics, including peak airway pressure (Ppeak), mean airway pressure (Pmean), positive end-expiratory pressure (PEEP), end-tidal CO2 (ETCO2), tidal volume (VT), respiratory rate (RR), and minute ventilation (MV), were taken at various intervals. Hemodynamic parameters such as systolic and diastolic blood pressures and heart rate were continuously monitored.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-14', 'studyFirstSubmitDate': '2024-08-12', 'studyFirstSubmitQcDate': '2024-08-14', 'lastUpdatePostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PEEP', 'timeFrame': '5, 15, and 30 minutes after positioning in the prone position', 'description': 'positive end-expiratory pressure'}, {'measure': 'ETCO2', 'timeFrame': '5, 15, and 30 minutes after positioning in the prone position', 'description': 'end-tidal carbon dioxide'}, {'measure': 'VT', 'timeFrame': '5, 15, and 30 minutes after positioning in the prone position', 'description': 'tidal volume'}, {'measure': 'Ppeak', 'timeFrame': '5, 15, and 30 minutes after positioning in the prone position', 'description': 'peak airway pressure'}, {'measure': 'Pmean', 'timeFrame': '5, 15, and 30 minutes after positioning in the prone position', 'description': 'mean airway pressure'}, {'measure': 'RR', 'timeFrame': '5, 15, and 30 minutes after positioning in the prone position', 'description': 'Respiratory Rate'}, {'measure': 'MV', 'timeFrame': '5, 15, and 30 minutes after positioning in the prone position', 'description': 'Minute volume'}, {'measure': 'Cdyn', 'timeFrame': 'in the supine position after intubation and in the prone position at the 30th minute', 'description': 'Dynamic. compliance'}, {'measure': 'PaO2/FiO2', 'timeFrame': 'in the prone position at the 30th minute', 'description': 'Partial Oxygen pressure/traction of inspired oxygen'}, {'measure': 'Vd/Vt', 'timeFrame': 'in the prone position at the 30th minute', 'description': 'dead space/tidal volume'}], 'secondaryOutcomes': [{'measure': 'HR', 'timeFrame': '5, 15, and 30 minutes after positioning in the prone position', 'description': 'Heart Rate'}, {'measure': 'SBP', 'timeFrame': '5, 15, and 30 minutes after positioning in the prone position', 'description': 'Systolic Blood Pressure'}, {'measure': 'DBP', 'timeFrame': '5, 15, and 30 minutes after positioning in the prone position', 'description': 'Diastolic BloodPressure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Total intravenous anesthesia', 'Sevoflurane', 'Respiratory mechanics,', 'Hemodynamic parameters', 'Spinal surgery', 'Prone position'], 'conditions': ['Spinal Stenosis, Lumbosacral Region']}, 'descriptionModule': {'briefSummary': 'Key Points:\n\n1. Objective:\n\n o To compare the effects of Total Intravenous Anesthesia (TIVA) and sevoflurane anesthesia on respiratory mechanics, hemodynamic parameters, and neuromonitoring during prone position spinal surgeries.\n2. Methodology:\n\n * A randomized controlled trial involving 52 patients scheduled for lumbar spine surgery, randomly assigned to either TIVA or sevoflurane groups.\n * Respiratory and hemodynamic parameters were measured at various time points.\n3. Results:\n\n * No significant differences were found between the TIVA and sevoflurane groups in terms of respiratory mechanics or hemodynamic stability.\n * Both anesthesia techniques maintained stable intraoperative conditions.\n4. Clinical Implications:\n\n * Anesthesiologists can flexibly choose between TIVA and sevoflurane based on patient-specific factors and surgical requirements.\n * TIVA may be preferred in surgeries with high neurological risk due to its compatibility with neuromonitoring.\n5. Future Research:\n\n * Studies with broader patient populations and long-term outcomes are needed to further refine anesthesia management strategies.\n * Research on the environmental impact and cost-effectiveness of anesthesia techniques is also important.', 'detailedDescription': 'This study aims to evaluate the impact of total intravenous anesthesia (TIVA) versus sevoflurane anesthesia on respiratory mechanics and hemodynamic parameters during spinal surgery performed in the prone position. Anesthesia management for spinal surgeries in the prone position is particularly challenging due to significant physiological changes. Identifying the effects of different anesthesia techniques is essential to enhance patient outcomes and ensure intraoperative stability. This randomized controlled trial involved 52 patients scheduled for lumbar spine surgery under general anesthesia. Participants were randomly allocated to either the TIVA group (n=26) or the sevoflurane group (n=26). Measurements of respiratory mechanics, including peak airway pressure (Ppeak), mean airway pressure (Pmean), positive end-expiratory pressure (PEEP), end-tidal CO2 (ETCO2), tidal volume (VT), respiratory rate (RR), and minute ventilation (MV), were taken at various intervals. Hemodynamic parameters such as systolic and diastolic blood pressures and heart rate were continuously monitored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The study included male and female patients aged 18 to 65 years who were scheduled for lumbar spine surgery under general anesthesia. Patients were categorized based on the American Society of Anesthesiologists (ASA) physical status levels I, II, and III.\n\nExclusion Criteria:\n\n* Diagnosis of asthma or chronic obstructive pulmonary disease (COPD)\n* Major cardiac conditions, such as recent myocardial infarction or a left ventricular ejection fraction (EF) less than 55%\n* Atrioventricular blocks of second and third degrees\n* Allergies to any drugs\n* Severe neurological disorders\n* History of sedative or opioid use'}, 'identificationModule': {'nctId': 'NCT06558695', 'acronym': 'TIVA', 'briefTitle': 'Stability Comparison of TIVA and Sevoflurane in Prone Spinal Surgery(TIVA:Total Intravenous Anesthesia)', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': 'Comparison of TIVA and Sevoflurane: Affirming Hemodynamic, Respiratory, and Neuromonitoring Stability in Prone Position Spinal Surgeries', 'orgStudyIdInfo': {'id': 'SaglikBilimleriU-KLKSH-Anes-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sevoflurane Group', 'description': 'In the Sevoflurane group, general anesthesia was maintained with sevoflurane at 0.8-1.0 minimum alveolar concentration (MAC).', 'interventionNames': ['Drug: Sevoflurane']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TIVA group', 'description': 'In the TIVA (Total Intra Venous Anesthesia) group, a combination of propofol (50-150 μg/kg/min) and remifentanil (0.02-0.2 μg/kg/min) was used for general anesthesia instead of inhalational agents.', 'interventionNames': ['Drug: TIVA']}], 'interventions': [{'name': 'Sevoflurane', 'type': 'DRUG', 'description': 'Sevoflurane was managed for maintenance of the general anestesia during spinal surgeries', 'armGroupLabels': ['Sevoflurane Group']}, {'name': 'TIVA', 'type': 'DRUG', 'otherNames': ['Total Intra Venous Anesthesia'], 'description': 'TIVA was managed for maintenance of the general anesthesia during spinal surgeries', 'armGroupLabels': ['TIVA group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Saglik Bilimleri Universitesi', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Yücel Yüce, MD,Assoc Prf', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saglik Bilimleri Universitesi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'YÜCEL YÜCE', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi'}}}}