Reducing Hypotensive Anesthesia Use With TXA During Orthognathic Surgery

Study Overview
=================
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.

Official Title
-----------------
Does Tranexamic Acid Reduce the Need for Deliberate Hypotensive Anesthesia Within Orthognathic Surgery? A Prospective Study

Conditions
-----------------
Hypotension During Surgery, Blood Loss, Surgical

Intervention / Treatment
-----------------
* Other: Avoidance of Deliberate Hypotensive Anesthesia
* Drug: TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model 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. 1g of tranexamic acid will be given perioperatively as already routinely performed. The anesthesia team will be asked to avoid deliberate hypotensive anesthesia and maintain blood pressure closer to patient baseline.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients Receiving Tranexamic Acid with Avoidance of Hypotensive Anesthesia<br> | Other: Avoidance of Deliberate Hypotensive Anesthesia<br>* The anesthesia team will be asked to avoid deliberate hypotensive anesthesia and maintain blood pressure closer to the patient's baseline throughout the surgery.<br>Drug: TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION<br>* 1g of tranexamic acid will be given intravenously to patient undergoing orthognathic surgery as routinely performed about 5-15 minutes before first surgical incision.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgeon's Analysis of Surgical Field Visualization | The surgeon will evaluate surgical field visibility using Fromme's ordinal scale | 1 year | 
| Mean Arterial Pressure | 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. | 1 year | 
| Estimated Blood Loss | Volume of blood loss recorded during surgical case | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
orthognathic surgery