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Reducing Hypotensive Anesthesia Use with TXA During Orthognathic Surgery

NCT05474027 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-12-19

No results posted yet for this 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.

Conditions

  • Hypotension During Surgery
  • Blood Loss, Surgical

Interventions

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.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Brian Kinard, DMD, MD · University of Alabama at Birmingham

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-11
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05474027 on ClinicalTrials.gov