Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-03 @ 12:41 AM
Study NCT ID:
NCT03394833
Status:
COMPLETED
Last Update Posted:
2019-09-26
First Post:
2017-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemodynamic Stability During Induction of Anaesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011097', 'term': 'Polygeline'}], 'ancestors': [{'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Non-blinded randomization. Standardized method comparison.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-25', 'studyFirstSubmitDate': '2017-11-17', 'studyFirstSubmitQcDate': '2018-01-08', 'lastUpdatePostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of blood pressure drops', 'timeFrame': '20 minutes post anesthesia induction', 'description': 'blood pressure drop below mean arterial pressure at 65 mmHg during anesthesia induction'}, {'measure': 'Effect of preoperative fluid bolus', 'timeFrame': '20 minutes post anesthesia induction', 'description': 'Does preoperative fluid bolus decrease incidence of blood pressure drops'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['preoperative', 'fluid therapy', 'hemodynamics', 'anesthesia induction', 'rapid sequence induction', 'TCI'], 'conditions': ['Hemodynamic Instability', 'Fluid Therapy', 'Anesthesia; Adverse Effect']}, 'referencesModule': {'references': [{'pmid': '31240711', 'type': 'DERIVED', 'citation': 'Myrberg T, Lindelof L, Hultin M. Effect of preoperative fluid therapy on hemodynamic stability during anesthesia induction, a randomized study. Acta Anaesthesiol Scand. 2019 Oct;63(9):1129-1136. doi: 10.1111/aas.13419. Epub 2019 Jun 26.'}]}, 'descriptionModule': {'briefSummary': 'The study aim is to investigate if preoperative volume bolus based on lean body weight could preserve mean arterial pressure during target controlled infusion of anaesthesia (TCI) or rapid sequence induction of anaesthesia (RSI) in non-cardiac, non-morbidly obese surgery.', 'detailedDescription': '40 individuals are enrolled to TCI and RSI groups respectively. The randomization process for preoperative fluid bolus prior to induction of anaesthesia is conducted in respective group at the day of surgery. Preoperative colloid fluid therapy (6 ml/kg LBW, Gelofusine™, Fresenius Kabi Ab, Sweden) is infused rapidly before non-invasive baseline blood pressure (NIBP) measurements in twenty individuals in each group. No other intravenous fluids before induction of anaesthesia.\n\nNIBPs, pulse frequency, peripheral saturation (SpO2) are registered and collected 20 minutes post induction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 80 individuals over 18 years, body mass index ≤ 35 kg/m2, electively scheduled for breast cancer surgery, endocrinologic surgery (thyroid, parathyroid) and general abdominal surgery.\n\nExclusion Criteria:\n\n* instable angina pectoris at the day of surgery, severe bronchial asthma or COPD.'}, 'identificationModule': {'nctId': 'NCT03394833', 'briefTitle': 'Hemodynamic Stability During Induction of Anaesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Umeå University'}, 'officialTitle': 'Hemodynamic Stability During an Induction of Anaesthesia: A Randomized, Non-blinded Study', 'orgStudyIdInfo': {'id': '2016/361-31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Preoperative fluids', 'description': '40 individuals receiving preoperative colloid fluid bolus at 6 ml/kg LBW, (Gelofusine™, Fresenius Kabi AB, Sweden) before anesthesia induction by TCI (n = 20) or RSI (n =20).', 'interventionNames': ['Other: gelofusine']}, {'type': 'NO_INTERVENTION', 'label': 'No preoperative fluids', 'description': '40 individuals anesthetized by TCI (n = 20) or RSI (n =20) without preoperative fluids.'}], 'interventions': [{'name': 'gelofusine', 'type': 'OTHER', 'otherNames': ['colloid fluid'], 'description': 'Preoperative colloid fluid bolus 6ml/kg ideal body weight', 'armGroupLabels': ['Preoperative fluids']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97180', 'city': 'Luleå', 'country': 'Sweden', 'facility': 'Sunderby hospital', 'geoPoint': {'lat': 65.58415, 'lon': 22.15465}}], 'overallOfficials': [{'name': 'Tomi P Myrberg, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Umeå University, Norrbotten county concil'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umeå University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Tomi Myrberg', 'investigatorAffiliation': 'Umeå University'}}}}