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Starting soon Observational

Tranexamic Acid Dose and Remifentanil Titration in Septorhinoplasty

NCT07450794 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2026-03-05
Last updated
2026-03-05

Condition(s) studied

Anesthesiologist Workload

Investigational drug(s) / intervention(s)

NASA Task Load Index (NASA-TLX)

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.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Intraoperative Remifentanil Titration Frequency — Intraoperative period (from induction of anesthesia to end of surgery).
    Total number of intraoperative remifentanil infusion rate adjustments (each increase or decrease counted as one intervention) recorded during septorhinoplasty.

Trial sites (1)

FacilityCityRegionStatus
Istinye Üniversity Istanbul Merkez Mahallesi
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07450794 on ClinicalTrials.gov ↗ ← All trials in Turkey