Tranexamic Acid Dose and Remifentanil Titration in Septorhinoplasty (NCT07450794) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Tranexamic Acid Dose and Remifentanil Titration in Septorhinoplasty
Turkey (Türkiye)90 participantsStarted 2026-03-05
Plain-language 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).
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intraoperative Remifentanil Titration Frequency
Timeframe: Intraoperative period (from induction of anesthesia to end of surgery).