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

Completed

• Conditions: Blood Pressure, Low

• Registration Number: NCT03086694
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-02-06
• Status Verified: 2017-03
• Study First Submitted QC: 2017-03-15
• Study First Posted: 2017-03-22
• Study Start: 2017-04-05
• Primary Completion: 2019-08-25
• Study Completion: 2019-08-31
• Last Update Submitted: 2024-06-19
• Last Update Posted: 2024-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
blood loss measurement	10hrs	to maintain low blood pressure (MAP \> 55mmHg) to limit blood loss

Secondary Outcome Measures

Name	Time	Method
assessment of inappropriate fluid infusion	10hours	count the fluid given by stroke volume variation but fixed time administration
postoperative adverse events	2 days	adequate medications to maintain low stable BP to decrease tissue edematous change

Trial Locations

Locations (1)

Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan