Tranexamic Acid Dose and Remifentanil Titration in Septorhinoplasty

NCT07450794 | Not Yet Recruiting

• 1 other identifier: TXA SRP
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Anesthesiologist Workload

Outcome Measures

Primary Outcomes (1)

• Intraoperative Remifentanil Titration Frequency

  Total number of intraoperative remifentanil infusion rate adjustments (each increase or decrease counted as one intervention) recorded during septorhinoplasty.

  Intraoperative period (from induction of anesthesia to end of surgery).

Interventions

NASA Task Load Index (NASA-TLX) OTHER

Postoperative assessment of anesthesiologist workload using the NASA Task Load Index (raw scoring method), completed immediately after each operation by the attending anesthesiologist.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Istinye Üniversity

Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)

Location

Related Publications (4)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

Central Study Contacts

ilke dolgun

CONTACT

+905555485632; ilkeser2004@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. prof

Study Record Dates

• First Submitted: March 1, 2026
• First Posted: March 5, 2026
• Study Start: March 5, 2026
• Primary Completion: August 5, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

TU (1)