Clinical trial NCT03086694: Goal-Directed Fluid Therapy for Patients Undergoing Oro-Maxillofacial Surgery
Official title: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure, Low
Keywords: oromaxillofacial surgery
nasotracheal intubation
stroke volume variation
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who need to operate for abnormal face or abnormal teeth biting

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.

Eligibility criteria: 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

Primary outcomes:
measure: blood loss measurement
timeFrame: 10hrs
Secondary outcomes:
measure: assessment of inappropriate fluid infusion
timeFrame: 10hours
measure: postoperative adverse events
timeFrame: 2 days
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
affiliation: Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital
name: kuang I Cheng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee MC, Tseng KY, Shen YC, Lin CH, Hsu CW, Hsu HJ, Lu IC, Cheng KI. Nasotracheal intubation in patients with limited mouth opening: a comparison between fibreoptic intubation and the Trachway(R). Anaesthesia. 2016 Jan;71(1):31-8. doi: 10.1111/anae.13232. Epub 2015 Oct 12.