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Tranexamic Acid Dose and Remifentanil Titration in Septorhinoplasty

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07450794
Enrollment
90
Registered
2026-03-05
Start date
2026-03-05
Completion date
2026-08-15
Last updated
2026-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesiologist Workload

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).

Interventions

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

Sponsors

Istinye University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 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

Design outcomes

Primary

MeasureTime frameDescription
Intraoperative Remifentanil Titration FrequencyIntraoperative 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.

Countries

Turkey (Türkiye)

Contacts

CONTACTilke dolgun
ilkeser2004@gmail.com+905555485632

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026