Reducing Hypotensive Anesthesia Use with TXA During Orthognathic Surgery

Phase 4

• Conditions: Blood Loss, Surgical; Hypotension During Surgery
• Interventions: Other: Avoidance of Deliberate Hypotensive Anesthesia; Drug: TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION

• Registration Number: NCT05474027
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Study Timeline

• Study First Submitted: 2022-07-20
• Study First Submitted QC: 2022-07-22
• Study First Posted: 2022-07-26
• Study Start: 2022-11-11
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-19
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients Receiving Tranexamic Acid with Avoidance of Hypotensive Anesthesia	TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION	-
Patients Receiving Tranexamic Acid with Avoidance of Hypotensive Anesthesia	Avoidance of Deliberate Hypotensive Anesthesia	-

Primary Outcome Measures

Name	Time	Method
Mean Arterial Pressure	1 year	Tracking mean arterial pressures throughout surgery, evaluating if patient's blood pressure can be reliably kept around patient's baseline instead of deliberate hypotensive anesthesia.
Estimated Blood Loss	1 year	Volume of blood loss recorded during surgical case
Surgeon's Analysis of Surgical Field Visualization	1 year	The surgeon will evaluate surgical field visibility using Fromme's ordinal scale

Trial Locations

Locations (1)

UAB Hospital-Highlands; 🇺🇸 Birmingham, Alabama, United States