Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT03961958
Status:
COMPLETED
Last Update Posted:
2019-05-23
First Post:
2019-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hemodynamic Changes and Propofol Pharmacokinetic Variation During Anesthesia Induction and Knee-chest Positioning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'In phase 1, target-controlled infusion propofol anesthesia was adjusted to maintain BIS 40 to 60.\n\nIn phase 2, there were 2 planned reductions in propofol target concentration: (1) immediately after loss of consciousness - reduction calculated using a predefined formula, and (2) before positioning - reduction equal to the average percentage decrease in CO after knee-chest position in phase 1.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-22', 'studyFirstSubmitDate': '2019-05-11', 'studyFirstSubmitQcDate': '2019-05-22', 'lastUpdatePostDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemodynamic changes', 'timeFrame': 'Baseline (moment 0), 10 minutes after induction of anesthesia (moment 1), 10 minutes after knee-chest positioning (moment 2)', 'description': 'Changes from baseline in cardiac output and comparison of the changes between both groups.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic changes', 'timeFrame': 'Baseline (moment 0), 10 minutes after induction of anesthesia (moment 1), 10 minutes after knee-chest positioning (moment 2)', 'description': 'Correlation between propofol measured plasma concentrations and predicted plasma concentrations (Cp) by the Schnider Pk model.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemodynamics', 'Knee-Chest Position', 'Propofol', 'Anesthesia, General', 'Anesthetics, Intravenous', 'pharmacokinetics'], 'conditions': ['Hemodynamic Instability', 'Anesthesia', 'Surgery']}, 'descriptionModule': {'briefSummary': 'Induction of anesthesia and the knee-chest position are associated with hemodynamic changes that may impact patient outcomes.\n\nChanges from baseline in cardiac output and other hemodynamic variables following induction of anesthesia and knee-chest positioning were compared. Propofol plasma concentrations were also measured after induction of anesthesia and after the knee-chest position.\n\nThe aim of this study was to assess whether planned reductions in target-controlled infusion propofol concentrations attenuate the hemodynamic changes associated with anesthesia induction and knee-chest position.\n\nThe secondary aim was to quantify the variation in propofol measured plasma concentrations (Cm), both after induction and after KC positioning, and correlate them with predicted concentrations (Cp) by the Schnider Pk model.', 'detailedDescription': 'A total of 20 patients scheduled for elective lumbar spinal surgery in the knee-chest position were included. In addition to standard anesthesia monitoring, bispectral index and noninvasive cardiac output monitoring were undertaken. The study was carried out in 2 parts. In phase 1, target-controlled infusion propofol anesthesia was adjusted to maintain BIS 40 to 60. In phase 2, there were 2 planned reductions in propofol target concentration: (1) immediately after loss of consciousness: reduction calculated using a predefined formula, and (2) before positioning: reduction equal to the average percentage decrease in CO after knee-chest position in phase 1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Lumbar spinal condition for surgical treatment in knee-chest position\n\nExclusion Criteria:\n\n* Severe ischemic heart disease\n* Congestive heart failure\n* Atrial fibrillation or flutter\n* Body mass index \\> 35 kg/m2\n* Glasgow Coma Scale \\< 15\n* Dementia disease\n* History of drug abuse or addiction\n* Consumption of opioid medication\n* Pre-operative administration of midazolam'}, 'identificationModule': {'nctId': 'NCT03961958', 'briefTitle': 'Hemodynamic Changes and Propofol Pharmacokinetic Variation During Anesthesia Induction and Knee-chest Positioning', 'organization': {'class': 'OTHER', 'fullName': 'University of Salamanca'}, 'officialTitle': 'Relationship Between Hemodynamic Changes and Propofol Pharmacokinetic Variation During Anesthesia Induction and Knee-chest Positioning in Propofol TCI Guided Anesthesia', 'orgStudyIdInfo': {'id': 'USalamanca'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No protocolled propofol reduction', 'description': 'In phase 1, target-controlled infusion propofol anesthesia was adjusted to maintain BIS 40 to 60.'}, {'type': 'EXPERIMENTAL', 'label': 'Two protocolled propofol reductions', 'description': 'In phase 2, there were 2 planned reductions in propofol target concentration: (1) immediately after loss of consciousness-reduction calculated using a predefined formula, and (2) before positioning-reduction equal to the average percentage decrease in CO after knee-chest position in phase', 'interventionNames': ['Drug: Propofol reduction']}], 'interventions': [{'name': 'Propofol reduction', 'type': 'DRUG', 'description': 'Reduction of propofol target concentration', 'armGroupLabels': ['Two protocolled propofol reductions']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Porto', 'country': 'Portugal', 'facility': 'Centro Hospitalar do Porto', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}], 'overallOfficials': [{'name': 'Consuelo S Sanchez, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Salamanca, Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'starting 6 months from publication, for 1 year', 'ipdSharing': 'YES', 'description': 'all IPD that underlie results in a publication will be shared', 'accessCriteria': 'everyone who asks for access after the explanation'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Salamanca', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centro Hospitalar do Porto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Daniela Chalo', 'investigatorAffiliation': 'University of Salamanca'}}}}