- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05316545
Retrospective Analysis of Anesthesia Procedure in Orthognathic Surgery
Study Overview
Status
Conditions
Detailed Description
In Orthognathic surgery, facial bones involved in the operation site are more likely to bleed. In order to reduce the amount of bleeding during the operation, intentional hypotensive anesthesia is executed during the operation.
Because the amount of bleeding is controlled within a reasonable range, the surgical field of vision is naturally clear, which can also make the operation go smoothly, shorten the operation time, and increase the postoperative comfort. Therefore, for orthognathic surgery, the maintenance of intraoperative blood pressure is very important. Using inhaled anesthetics can easily achieve deeper anesthesia, but may increase postoperative nausea and vomiting. Generally speaking, these patients will be fixed with steel wires between the upper and lower jaws after the operation. Postoperative nausea and vomiting will increase the risk of aspiration pneumonia, but intravenous anesthesia can reduce postoperative nausea and vomiting.
This research is a retrospective investigation of medical records. The purpose of this study is to understand the differences in the analysis of the correlation between the operation time, blood loss, anesthesia method, anesthesia medication, and postoperative recovery of patients undergoing surgery during orthognathic surgery. In the future, orthognathic surgery (Orthognathic surgery) anesthesia policy and anesthesia target process guidelines can be formulated, and it can help remind medical staff to make an early and appropriate treatment at any time.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Sanmin Dist
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Kaohsiung, Sanmin Dist, Taiwan, 80756,
- Kaohsiung Medical University Chung-Ho Memorial Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients undergoing conventional anesthesia surgery and orthognathic surgery.
Exclusion Criteria:
- Exclude the operation time greater than 8 hours.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
medical treatment events performed
Time Frame: During procedure
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The purpose of the study is to analyze the cases of orthognathic surgery in our hospital from 2010 to 2021 and find out which medical treatment events must be performed while maintaining Intentional hypotension such as inhaled anesthetics, pain relievers, Nitroglycerine, target controlled infusion, Precedex, Opioid, antagonist also the timing when the medical treatment intervene.
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During procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
time of anesthesia,lose of blood and recovery after surgery
Time Frame: During procedure
|
The secondary outcome will be analyzed for whether the medical treatment event would affect the time of anesthesia and loose of blood during the operative, and recovery after surgery,etc.
We will collect the following data from electronic medical records: age, gender, weight, height, body mass index (BMI), preoperative American Society of Anesthesiologists (ASA) score, duration of anesthesia, type of anesthesia, anesthetic drugs, operation time, types of operation, estimated intraoperative blood loss (EBL), preoperative and postoperative Hemoglobin (HGB) and hematocrit (HCT), as well as postoperative recovery and statistically analyze the data by t-test and one-way ANOVA to get the mean and standard deviation of them.
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During procedure
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Collaborators and Investigators
Investigators
- Principal Investigator: Kuang-I Cheng, Phd, Kaohsiung Medical University Chung-Ho Memorial Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- KMUHIRB-E(I)-20210262
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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