NCT05474027

Reducing Hypotensive Anesthesia Use with TXA During Orthognathic Surgery

Does Tranexamic Acid Reduce the Need for Deliberate Hypotensive Anesthesia Within Orthognathic Surgery? a Prospective Study

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed description

Our goal is to enroll 50 patients. Patients will be recruited from Dr. Kinard's regularly scheduled orthognathic cases at UAB Highlands Hospital. The patient will be informed of the study in advance and have consent signed pre-operatively. Patients will be evaluated for the following variables: sex, age, weight at time of surgery, preoperative hemoglobin, and preoperative hematocrit. Patients will be included if they are undergoing bimaxillary orthognathic surgery at UAB Highlands Hospital. All patients treated with orthognathic surgery already are provided 1g of TXA perioperatively and this will be continued through this study. All patients will be treated with 1g of TXA perioperatively and the anesthesia team will be instructed to limit deliberate hypotensive anesthesia unless otherwise directed by the surgeon. Perioperative and post-operative measurements will include: estimated blood loss, pre and post-operative hemoglobin, pre and post-operative hematocrit, average mean arterial pressure throughout the case (MAP), maximum MAP (excluding induction and emergence), minimum MAP (excluding induction and emergence), total MAP time under 65 mmHg, length of procedure, and surgeon evaluation of visual field throughout the procedure utilizing Fromme's ordinal scale. Based on these factors, it will help determine the need for deliberate hypotensive anesthesia during orthognathic surgery when tranexamic acid is administered.

Conditions

• Hypotension During Surgery
• Blood Loss, Surgical

Interventions

Type	Name	Description
OTHER	Avoidance of Deliberate Hypotensive Anesthesia	The anesthesia team will be asked to avoid deliberate hypotensive anesthesia and maintain blood pressure closer to the patient's baseline throughout the surgery.
DRUG	TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION	1g of tranexamic acid will be given intravenously to patient undergoing orthognathic surgery as routinely performed about 5-15 minutes before first surgical incision.

Timeline

• Start date: 2022-11-11
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2022-07-26
• Last updated: 2024-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study