Phase 4
N=115
Reducing Hypotensive Anesthesia Use With TXA During Orthognathic Surgery
Hypotension During Surgery · Blood Loss, Surgical
Bottom Line
View on ClinicalTrials.gov: NCT05474027 ↗Enrolled (actual)
115
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Surgeon's Analysis of Surgical Field Visualization — 1.3 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Avoidance of Deliberate Hypotensive Anesthesia (Other); TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Nov 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Surgeon's Analysis of Surgical Field Visualization |
1.3 | — |
| PRIMARY Percentage of Hours to Maintain a Mean Arterial Pressure |
14.3 | — |
| PRIMARY Average Volume of Blood Loss on a Scale |
1.3 | — |
Summary
This prospective study will analyze the need for deliberate hypotensive anesthesia (DHA) during orthognathic surgery when tranexamic acid (TXA) is administered. DHA has been proven to be effective although it comes with multiple risks related to organ hypoperfusion including kidney injury, stroke, and cardiac ischemia. Therefore, it may be potentially safer for patients to avoid deliberate hypotensive anesthesia if TXA alone adequately controls blood loss and provides adequate surgical site visualization.
Eligibility Criteria
Inclusion Criteria
- Bimaxillary orthognathic surgery completed at UAB Highlands Hospital
Exclusion Criteria
- History of hypertension or previously diagnosed cardiac problems
- Bleeding diathesis
- TXA medically contraindicated
Data sourced from ClinicalTrials.gov (NCT05474027). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.