Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:48 AM
Study NCT ID:
NCT07450794
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-05
First Post:
2026-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tranexamic Acid Dose and Remifentanil Titration in Septorhinoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-01', 'studyFirstSubmitDate': '2026-03-01', 'studyFirstSubmitQcDate': '2026-03-01', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative Remifentanil Titration Frequency', 'timeFrame': 'Intraoperative period (from induction of anesthesia to end of surgery).', 'description': 'Total number of intraoperative remifentanil infusion rate adjustments (each increase or decrease counted as one intervention) recorded during septorhinoplasty.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anesthesiologist Workload']}, 'referencesModule': {'references': [{'pmid': '38097691', 'type': 'RESULT', 'citation': 'Gutierrez RWH, Gobbo HR, Heringer LDFL. Tranexamic Acid in Patients Undergoing Rhinoplasty: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials. Aesthetic Plast Surg. 2024 Jun;48(11):2076-2085. doi: 10.1007/s00266-023-03768-3. Epub 2023 Dec 14.'}, {'pmid': '40316735', 'type': 'RESULT', 'citation': 'Yang C, Ji B, Li G, Zhang X, Xu B, Maimaitiming A, Cao L. Weight-based tranexamic acid lowers the risk of postoperative blood loss and transfusion requirements compared with fixed-dose regimen in revision knee arthroplasty: a comparative study. J Orthop Traumatol. 2025 May 2;26(1):26. doi: 10.1186/s10195-025-00844-z.'}, {'pmid': '40975121', 'type': 'RESULT', 'citation': 'Weber TM Jr, Squier B, Kinard BE. Is Tranexamic Acid Associated With a Reduced Need for Hypotensive Anesthesia During Orthognathic Surgery? J Oral Maxillofac Surg. 2025 Dec;83(12):1470-1477. doi: 10.1016/j.joms.2025.08.013. Epub 2025 Sep 4.'}, {'pmid': '35979975', 'type': 'RESULT', 'citation': 'Favre-Felix J, Dziadzko M, Bauer C, Duclos A, Lehot JJ, Rimmele T, Lilot M. High-Fidelity Simulation to Assess Task Load Index and Performance: A Prospective Observational Study. Turk J Anaesthesiol Reanim. 2022 Aug;50(4):282-287. doi: 10.5152/TJAR.2022.21234.'}]}, 'descriptionModule': {'briefSummary': 'This prospective observational cohort study aims to investigate whether the weight-based equivalent (mg/kg) of a fixed 1 g dose of tranexamic acid administered during septorhinoplasty is associated with intraoperative remifentanil titration frequency and perceived anesthesiologist workload. Although tranexamic acid is routinely given as a fixed dose, its mg/kg equivalent varies according to patient weight and may influence hemodynamic management during controlled hypotension. The primary outcome is the total number of remifentanil infusion rate adjustments during surgery. Secondary outcomes include total remifentanil consumption and postoperative anesthesiologist workload assessed using the NASA Task Load Index (NASA-TLX).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients (18-70 years) undergoing elective septorhinoplasty under general anesthesia at a tertiary academic hospital. All patients receive a fixed 1 g intravenous dose of tranexamic acid as part of routine clinical practice, and intraoperative management includes a controlled hypotension strategy. Consecutive eligible patients with complete perioperative data are included in this prospective observational cohort.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Elective septorhinoplasty under general anesthesia\n* Intraoperative administration of fixed 1 g intravenous tranexamic acid as part of routine practice\n* Controlled hypotension strategy applied intraoperatively\n* Surgery duration between 60-240 minutes\n* Complete intraoperative hemodynamic and drug titration records available\n\nExclusion Criteria:\n\n* Emergency surgery\n* Additional major surgical procedure performed in the same session\n* Known coagulation disorder\n* Contraindication to tranexamic acid\n* History of thromboembolic disease\n* Chronic opioid use or opioid tolerance\n* Chronic pain syndrome\n* Regular use of sedatives, benzodiazepines, or CNS depressants\n* Severe cardiac, renal, or hepatic failure\n* Uncontrolled hypertension or significant arrhythmia\n* Preoperative hemoglobin \\<10 g/dL\n* Major intraoperative complication\n* Incomplete or missing intraoperative data'}, 'identificationModule': {'nctId': 'NCT07450794', 'briefTitle': 'Tranexamic Acid Dose and Remifentanil Titration in Septorhinoplasty', 'organization': {'class': 'OTHER', 'fullName': 'Istinye University'}, 'officialTitle': 'Association Between Weight-Based Equivalent of Fixed 1 g Tranexamic Acid and Intraoperative Remifentanil Titration Frequency and Anesthesiologist Workload in Septorhinoplasty: A Prospective Observational Cohort Study', 'orgStudyIdInfo': {'id': 'TXA SRP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'NASA Task Load Index (NASA-TLX)', 'type': 'OTHER', 'description': 'Postoperative assessment of anesthesiologist workload using the NASA Task Load Index (raw scoring method), completed immediately after each operation by the attending anesthesiologist.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34250', 'city': 'Istanbul', 'state': 'Merkez Mahallesi', 'country': 'Turkey (Türkiye)', 'facility': 'Istinye Üniversity', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'ilke dolgun', 'role': 'CONTACT', 'email': 'ilkeser2004@gmail.com', 'phone': '+905555485632'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istinye University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. prof', 'investigatorFullName': 'İlke Dolgun', 'investigatorAffiliation': 'Istinye University'}}}}