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Reducing Hypotensive Anesthesia Use with TXA During Orthognathic Surgery

NCT ID: NCT05474027

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-11

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Hypotension During Surgery Blood Loss, Surgical

Keywords

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orthognathic surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients Receiving Tranexamic Acid with Avoidance of Hypotensive Anesthesia

Group Type EXPERIMENTAL

Avoidance of Deliberate Hypotensive Anesthesia

Intervention Type OTHER

The anesthesia team will be asked to avoid deliberate hypotensive anesthesia and maintain blood pressure closer to the patient's baseline throughout the surgery.

TRANEXAMIC ACID 1 G in 10 mL INTRAVENOUS INJECTION, SOLUTION

Intervention Type DRUG

1g of tranexamic acid will be given intravenously to patient undergoing orthognathic surgery as routinely performed about 5-15 minutes before first surgical incision.

Interventions

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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.

Intervention Type OTHER

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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Brian Kinard

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brian Kinard, DMD, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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UAB Hospital-Highlands

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-300009440

Identifier Type: -

Identifier Source: org_study_id