Tranexamic Acid Dose and Remifentanil Titration in Septorhinoplasty
ConditionAnesthesiologist Workload
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorIstinye University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Emergency surgery
Additional major surgical procedure performed in the same session
Known coagulation disorder
Contraindication to tranexamic acid
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
NASA Task Load Index (NASA-TLX)
Other interventionPostoperative assessment of anesthesiologist workload using the NASA Task Load Index (raw scoring method), completed immediately after each operation by the attending anesthesiologist.
Treatment groups
No treatment groups listed
Trial outcomes
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.
Time frame
Intraoperative period (from induction of anesthesia to end of surgery).Sponsors and contacts
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Source ClinicalTrials.gov
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