Orthognathic SurgeryNCT05316545
Retrospective Analysis of Anesthesia Procedure in Orthognathic Surgery
An observational study of Orthognathic Surgery, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Using retrospective medical records to analyze the difference between the analysis of the correlation between operation time, blood loss, anesthesia methods, anesthesia medication, and postoperative recovery time Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthognathic Surgery
- How many people
- 700 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Nov 2021to 15 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Review the operation time, blood loss, anesthesia method, anesthesia medication, and postoperative recovery evaluation of the operation record sheet and anesthesia-related record sheet (including the recovery room and postoperative visit record sheet) in the patient's medical record.
Who may be able to join
- Patients undergoing conventional anesthesia surgery and orthognathic surgery.
Who cannot join
- Exclude the operation time greater than 8 hours.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Sanmin Dist, 80756,
About this study
Using retrospective medical records to analyze the difference between the analysis of the correlation between operation time, blood loss, anesthesia methods, anesthesia medication, and postoperative recovery time
Read the 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.
- Conditions
- Orthognathic Surgery
- Keywords
- orthognathic surgery, anesthesia, retrospective analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
medical treatment events performed
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.
Measured: During procedure
Secondary outcomes (1)
time of anesthesia,lose of blood and recovery after surgery
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.
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start16 Nov 2021
- Primary completion15 Nov 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthognathic SurgeryStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kuang-I Cheng, Phd, Principal investigator, Kaohsiung Medical University Chung-Ho Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316545
- Sponsor's protocol ID
- KMUHIRB-E(I)-20210262
- Status last verified
- Dec 2021
- First submitted
- 10 Jan 2022
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Anesthesia Procedure in Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT05316545
- Acronym / sponsor ID
- KMUHIRB-E(I)-20210262
- Conditions
- Orthognathic Surgery
- Keywords
- orthognathic surgery, anesthesia, retrospective analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Using retrospective medical records to analyze the difference between the analysis of the correlation between operation time, blood loss, anesthesia methods, anesthesia medication, and postoperative recovery time
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 design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Review the operation time, blood loss, anesthesia method, anesthesia medication, and postoperative recovery evaluation of the operation record sheet and anesthesia-related record sheet (including the recovery room and postoperative visit record sheet) in the patient's medical record.
Key inclusion criteria (1 listed)
- Patients undergoing conventional anesthesia surgery and orthognathic surgery.
Key exclusion criteria (1 listed)
- Exclude the operation time greater than 8 hours.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
medical treatment events performed
Time frame: During procedure
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.
1 secondary outcome
time of anesthesia,lose of blood and recovery after surgery
Time frame: During procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuang-I Cheng, Phd principal investigator
Kaohsiung Medical University Chung-Ho Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthognathic Surgery, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
medical treatment events performed (time frame: During procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.