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

Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03086694
Collaborator
(none)
60
Enrollment
1
Location
32.9
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Kaohsiung Medical University Chung-Ho Memorial Hospital
    Actual Study Start Date :
    Apr 5, 2017
    Anticipated Primary Completion Date :
    Aug 25, 2019
    Anticipated Study Completion Date :
    Dec 31, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    group surgery

    using medications to maintain low stable blood pressure

    Outcome Measures

    Primary Outcome Measures

    1. blood loss measurement [10hrs]

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

    Secondary Outcome Measures

    1. assessment of inappropriate fluid infusion [10hours]

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

    2. postoperative adverse events [2 days]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung Taiwan 80765

    Sponsors and Collaborators

    • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Investigators

    • Principal Investigator: kuang I Cheng, MD, PhD, Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Kaohsiung Medical University Chung-Ho Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT03086694
    Other Study ID Numbers:
    • KMUHIRB-E(II)_20160110
    First Posted:
    Mar 22, 2017
    Last Update Posted:
    Mar 20, 2018
    Last Verified:
    Aug 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital
    oromaxillofacial surgery
    nasotracheal intubation
    stroke volume variation
    Additional relevant MeSH terms:
    Hypotension

    Study Results

    No Results Posted as of Mar 20, 2018