Goal-Directed Fluid Therapy for Patients Undergoing Oro-Maxillofacial Surgery
Kaohsiung Medical University Chung-Ho Memorial Hospital
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2017
CompletedFirst Posted
Study publicly available on registry
March 22, 2017
CompletedStudy Start
First participant enrolled
April 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2019
CompletedJune 21, 2024
March 1, 2017
2.4 years
February 6, 2017
June 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
blood loss measurement
to maintain low blood pressure (MAP \> 55mmHg) to limit blood loss
10hrs
Secondary Outcomes (2)
assessment of inappropriate fluid infusion
10hours
postoperative adverse events
2 days
Study Arms (1)
group surgery
using medications to maintain low stable blood pressure
Eligibility Criteria
patients who need to operate for abnormal face or abnormal teeth biting
You may qualify if:
- patients undergo orthognathic surgery, ASA I\~III, 20 to 65 years old, no mouth limitation
You may not qualify if:
- ankylosing spondylitis, limited mouth opening \< 3 cm, liver or renal disease, obese patients (BMI\>35kg/m2), patients refused
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80765, Taiwan
Related 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.
PMID: 26460721BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
kuang I Cheng, MD, PhD
Department of Anesthesiology, Kaohsiung Medical University Chung-Ho Memorial Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2017
First Posted
March 22, 2017
Study Start
April 5, 2017
Primary Completion
August 25, 2019
Study Completion
August 31, 2019
Last Updated
June 21, 2024
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share