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CompletedNCT03086694Updated Jun 21, 2024

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

An observational study in Blood Pressure, Low, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-06-21.

Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
20 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Blood Pressure, Low

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Keywords

  • oromaxillofacial surgery
  • nasotracheal intubation
  • stroke volume variation
03

In context

Hypotension

1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.

This study's enrollment of 60 is below the median of 84 across 294 observational studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 281 studies on the registry; 57 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients who need to operate for abnormal face or abnormal teeth biting

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • ankylosing spondylitis, limited mouth opening \< 3 cm, liver or renal disease, obese patients (BMI>35kg/m2), patients refused
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • group surgery

    using medications to maintain low stable blood pressure

06

What researchers measure

Primary outcomes

  1. blood loss measurement

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

    Time frame: 10hrs

Secondary outcomes

  1. assessment of inappropriate fluid infusion

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

    Time frame: 10hours

  2. postoperative adverse events

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

    Time frame: 2 days

07

Study locations

1 site
  • Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital
    Kaohsiung, 80765, Taiwan
08

References and documents

Publications

  • 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. PubMed 26460721 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03086694
Lead sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Responsible party
Sponsor
First posted
Mar 22, 2017
Start date
Apr 5, 2017
Primary completion
Aug 25, 2019
Completion
Aug 31, 2019
Last update
Jun 21, 2024

Study contacts

kuang I Cheng, MD, PhD
principal investigator · Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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