Tranexamic Acid Dose and Remifentanil Titration in Septorhinoplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NASA Task Load Index (NASA-TLX).
- Who it may be relevant to
- Registry conditions: Anesthesiologist Workload. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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).
Interventions
- Other NASA Task Load Index (NASA-TLX)
Postoperative assessment of anesthesiologist workload using the NASA Task Load Index (raw scoring method), completed immediately after each operation by the attending anesthesiologist.
Primary outcome measures
- Intraoperative Remifentanil Titration Frequency [Time frame: Intraoperative period (from induction of anesthesia to end of surgery).]
Eligibility criteria
Inclusion criteria
- Age ≥ 18 years
- Elective septorhinoplasty under general anesthesia
- Intraoperative administration of fixed 1 g intravenous tranexamic acid as part of routine practice
- Controlled hypotension strategy applied intraoperatively
- Surgery duration between 60-240 minutes
- Complete intraoperative hemodynamic and drug titration records available
Exclusion criteria
- Emergency surgery
- Additional major surgical procedure performed in the same session
- Known coagulation disorder
- Contraindication to tranexamic acid
- History of thromboembolic disease
- Chronic opioid use or opioid tolerance
- Chronic pain syndrome
- Regular use of sedatives, benzodiazepines, or CNS depressants
- Severe cardiac, renal, or hepatic failure
- Uncontrolled hypertension or significant arrhythmia
- Preoperative hemoglobin <10 g/dL
- Major intraoperative complication
- Incomplete or missing intraoperative data
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Istinye Üniversity — Istanbul
Publications
- 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 38097691
- 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 40316735
- 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 40975121
- 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. PMID 35979975
Identifiers
NCT: NCT07450794 · TXA SRP