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Completed

NCT Number: NCT03086694

Goal-Directed Fluid Therapy for Patients Undergoing Oro-Maxillofacial Surgery

Orthognathic surgery, one kind of Oro-maxillofacial surgery, is a complicate surgery that undergoes several hours with nasotracheal intubation general anesthesia. To limit blood loss during operation, the patients are often under intentional hypotension. However, the intentional hypotension may confuse with hypovolemic induced low blood pressure. The hypothesis is using flotrac (to measure stroke volume variation) to keep the patients hemodynamics stable under Tridil and propofol infusion and avoid over-infusion of crystalloid or colloid and prevent hypovolemia induced postoperative nausea and vomiting.

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Key information

Conditions

Blood Pressure, Low Cardiovascular Diseases Hypotension Vascular Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80765, Taiwan

About this study

Orthognathic surgery, one kind of oro-maxillofacial surgery, is a complicated surgery that undergoes several hours with nasotracheal intubation general anesthesia. Patients without premedication undergo orthognathic surgery with nasotracheal intubation general anesthesia.

Patients without premedications Monitoring of patients with entropy for consciousness, ECG, with noninvasive BP and invasive blood pressure through redial artery, train-of-four monitor, target controlled infusion of propofol, infusion Tridil, and sevoflurane for mainly anesthesia maintenance. Ventilator setting as volume control (8-12ml/kg), frequency respiratory rate (8-12/min), I/E ratio: 1/2, positive end expiratory pressure: 4 mmHg, Fraction inspiratory O2: 60%.

To maintain the MAP >60-55 mmHg, urine output 0.5-1ml/kg, and body core temperature > 36 Celsius degree.

Closely observation of patients postoperatively for adverse events or complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients undergo orthognathic surgery, ASA I~III, 20 to 65 years old, no mouth limitation

Exclusion criteria

  • ankylosing spondylitis, limited mouth opening < 3 cm, liver or renal disease, obese patients (BMI>35kg/m2), patients refused

Treatment and study plan

Primary outcomes

  1. blood loss measurement

    Time frame: 10hrs

    to maintain low blood pressure (MAP > 55mmHg) to limit blood loss

Secondary outcomes

  1. assessment of inappropriate fluid infusion

    Time frame: 10hours

    count the fluid given by stroke volume variation but fixed time administration

  2. postoperative adverse events

    Time frame: 2 days

    adequate medications to maintain low stable BP to decrease tissue edematous change

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Registry information

Official study title

Kaohsiung Medical University Chung-Ho Memorial Hospital

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 22, 2017
Registry last updated
Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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