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NCT05474027 · ClinicalTrials.gov registry record · Phase 4
Reducing Hypotensive Anesthesia Use With TXA During Orthognathic Surgery
A Phase 4 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 4
- Development phase
- 115
- Enrollment target
NCT05474027: Completed Phase 4 study, sponsored by University of Alabama at Birmingham.
NCT05474027 is a Phase 4 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 115 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05474027, a Phase 4 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 115 participants
- Enrollment target
Study 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.
Primary Outcome
The surgeon will evaluate surgical field visibility using Fromme's ordinal scale. Fromme's ordinal scale (often referred to as the Fromme-Boezaart scale) is a 5-point, 0-5 visual grading system used by surgeons to assess the quality of the surgical field, primarily based on bleeding and suction frequency. It measures surgical conditions from 0 (no bleeding, perfectly dry) to 5 (severe bleeding, flooding the field).
Interventions
- OTHER Avoidance of Deliberate Hypotensive Anesthesia
- DRUG TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2022-11-11 |
| Est. Completion | 2025-12-01 |
| Phase | Phase 4 |
What the finished NCT05474027 record still lists
NCT05474027 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Avoidance of Deliberate Hypotensive Anesthesia is the first listed.
NCT05474027 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05474027 about?
NCT05474027 is a clinical study titled "Reducing Hypotensive Anesthesia Use With TXA During Orthognathic Surgery". 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, a...
What is the current status of trial NCT05474027?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 115 participants. The study started on 2022-11-11. Estimated completion is 2025-12-01.
What interventions are being tested in trial NCT05474027?
The interventions under investigation include: Avoidance of Deliberate Hypotensive Anesthesia (OTHER), TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION (DRUG).
Who is sponsoring clinical trial NCT05474027?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05474027's enrollment target sits among peer trials
115 718th of 2000 higher than 1,281 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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