Tranexamic Acid Dose and Remifentanil Titration in Septorhinoplasty

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).

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Key information

Conditions

Anesthesiologist Workload

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istinye Üniversity

Istanbul, Merkez Mahallesi, 34250, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Intraoperative Remifentanil Titration Frequency

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

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CONTACT

[email protected]

+905555485632

Sponsors and collaborators

Lead sponsor

Istinye University

Other

Registry information

Official study 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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Mar 5, 2026
Registry last updated: Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.