UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056818 |
|---|---|
| Receipt number | R000064941 |
| Scientific Title | Elucidating bleeding-related factors in orthognathic jaw surgery under total intravenous anesthesia |
| Date of disclosure of the study information | 2025/01/26 |
| Last modified on | 2025/12/26 16:44:37 |
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Basic information
Public title
Elucidating bleeding-related factors in orthognathic jaw surgery under total intravenous anesthesia
Acronym
Elucidating bleeding-related factors in orthognathic jaw surgery under total intravenous anesthesia
Scientific Title
Elucidating bleeding-related factors in orthognathic jaw surgery under total intravenous anesthesia
Scientific Title:Acronym
Elucidating bleeding-related factors in orthognathic jaw surgery under total intravenous anesthesia
Region
| Japan |
Condition
Condition
jaw deformity
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidate bleeding-related factors in orthognathic jaw surgery under general anesthesia with propofol or remimazolam
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation of endpoints to blood loss
Key secondary outcomes
Gender, age, weight, medical history, blood work, years of surgeon experience, type of anesthetic (propofol, remimazolam), amount of fentanyl and remifentanil used, mean systolic blood pressure, coefficient of variation of systolic blood pressure (CVSBP), mean intraoperative heart rate, duration of surgery, amount of blood loss, amount of local anesthetic used, body temperature, urine volume
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Propofol group maintains general anesthesia with propofol
Interventions/Control_2
remimazolam group maintains general anesthesia with remimazolam
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 51 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing orthognathic surgery
ASA-PS 1-2
Patient who gave consent for this study
Key exclusion criteria
<20 or >50 years of age
ASA-PS 3 or higher
patient who did not give consent for this study
patient with a bleeding predisposition (disease, drugs)
emergency surgery
contraindicated for administration of medications used in this study
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | kyotarou |
| Middle name | |
| Last name | koshika |
Organization
Tokyo Dental College
Division name
Dental Anesthesiology
Zip code
101-0061
Address
2-9-18 Misakicyo,Chiyodaku,Tokyo-to 101-0061 Japan
TEL
03-6380-9001
koshikakyotarou@tdc.ac.jp
Public contact
Name of contact person
| 1st name | masanari |
| Middle name | |
| Last name | nakazawa |
Organization
Tokyo Dental College
Division name
Dental Anesthesiology
Zip code
101-0061
Address
2-9-18 Misakicyo,Chiyodaku,Tokyo-to 101-0061 Japan
TEL
03-6380-9001
Homepage URL
nakazawamasanari@tdc.ac.jp
Sponsor or person
Institute
Tokyo Dental College
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Dental College Ethics Review Board
Address
2-9-18 Misakicyo,Chiyodaku,Tokyo-to 101-0061 Japan
Tel
03-6380-9001
drinri@tdc.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Suspended
Date of protocol fixation
| 2025 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 26 | Day |
Last modified on
| 2025 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064941
