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

Blood Pressure, Low Clinical Trial

Official title:

Kaohsiung Medical University Chung-Ho Memorial Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03086694
• Other study ID #: KMUHIRB-E(II)_20160110
• Status: Completed
• Start date: April 5, 2017
• Est. completion date: August 31, 2019

Study information

• Verified date: March 2017
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 31, 2019
• Est. primary completion date: August 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure, Low
• Hypotension

Locations

Country	Name	City	State
Taiwan	Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	blood loss measurement	to maintain low blood pressure (MAP > 55mmHg) to limit blood loss	10hrs
Secondary	assessment of inappropriate fluid infusion	count the fluid given by stroke volume variation but fixed time administration	10hours
Secondary	postoperative adverse events	adequate medications to maintain low stable BP to decrease tissue edematous change	2 days