Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05316545
Other study ID # KMUHIRB-E(I)-20210262
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 16, 2021
Est. completion date November 15, 2022

Study information

Verified date December 2021
Source Kaohsiung Medical University Chung-Ho Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 700
Est. completion date November 15, 2022
Est. primary completion date November 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Patients undergoing conventional anesthesia surgery and orthognathic surgery. Exclusion Criteria: - Exclude the operation time greater than 8 hours.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung Sanmin Dist

Sponsors (1)

Lead Sponsor Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. During procedure
Secondary 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. During procedure
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05536596 - Pharmacological Treatment on the Recovery of Neurosensory Disturbance After Bilateral Sagittal Split Osteotomy Phase 2/Phase 3
Withdrawn NCT03318757 - Bupivacaine Liposomal Injectable Suspension, Pain and Narcotic Use After Elective Orthognathic Surgery Phase 4
Not yet recruiting NCT03486951 - Outpatient Orthognathic Surgery: "AMBOST" a One Year Study
Recruiting NCT05009056 - Functional Appliance for Orthognathic Surgery N/A
Recruiting NCT01989715 - Body Posture Assessment Considering Jaws Position Before and After Orthognathic Surgery on Adult Patient. N/A
Completed NCT01461031 - Effect of Nefopam on Acute Postoperative Pain in Patients Undergoing Orthognathic Surgery N/A
Completed NCT03986723 - 3D Printed Models in 3D Virtual Treatment Planning of Orthognathic Surgery
Completed NCT06233188 - Effect of Customized Lateral Nasal Wall Osteotomy on the Pterygomaxillary Separation During le Fort I Down-fracture N/A
Completed NCT03843138 - Feasibility and Performance of a Novel 3D Virtual Treatment Planning Software: an International, Multi-centric, Prospective Study
Not yet recruiting NCT06338982 - Fracture Pattern Following Bilateral Sagittal Split Osteotomy With or Without Impacted Third Molars N/A
Completed NCT06188403 - Comparison Between Prebent Plates and Custom Plates After le Fort 1 in Orthognathic Surgery N/A
Active, not recruiting NCT06400355 - Effect of Mannitol on Recovery Pattern After Orthognathic Surgery N/A
Completed NCT06301204 - Effectiveness Of Tranexamic Acıd Application Wıth Different Doses On Bleeding, Edema And Physician Comfort In Orthognathıc Surgery Patients N/A
Not yet recruiting NCT06093893 - Hypotensive Anesthesia for Orthognathic Surgery Phase 4
Not yet recruiting NCT04353635 - Prediction Accuracy of Dolphin 3D in Bimax Surgery for Class III
Withdrawn NCT03433144 - The Effects of Tranexamic Acid on Blood Loss During Orthognathic Surgery Phase 4
Completed NCT06103422 - Change in Taste Sensation After Orthognathic Surgery N/A
Suspended NCT04910074 - LLLT Effects on Inferior Alveolar Nerve (IAN) Recovery Post-orthognathic Surgery N/A
Recruiting NCT05717322 - TENS and Orthognathic Surgery N/A
Completed NCT05184725 - CARINAE for Stress Relief in Perioperative Care N/A