UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052516 |
|---|---|
| Receipt number | R000059928 |
| Scientific Title | Measuring the degree of venous dilatation based on changes in avascular blood pressure and avascularization time |
| Date of disclosure of the study information | 2023/10/17 |
| Last modified on | 2024/04/18 11:50:35 |
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Basic information
Public title
Measuring the degree of venous dilatation based on changes in avascular blood pressure and avascularization time
Acronym
Degree of venous dilatation due to changes in avascular conditions
Scientific Title
Measuring the degree of venous dilatation based on changes in avascular blood pressure and avascularization time
Scientific Title:Acronym
Degree of venous dilatation due to changes in avascular conditions
Region
| Japan |
Condition
Condition
Patients undergoing oral and oral surgery surgery under general anesthesia
Classification by specialty
| Anesthesiology | Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although the thickness of blood vessels varies from person to person, the apoptotic blood pressure and apoptotic time at which dilation reaches its maximum have not yet been investigated. This is because there is a possibility that the subject's mental state may be affected. This research will be conducted under general anesthesia, making it highly scientifically rational.
Basic objectives2
Others
Basic objectives -Others
Appropriate avascular blood pressure and avascularization time
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Vein cross-sectional area
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Blood aversion with mean blood pressure + pulse pressure
Interventions/Control_2
Blood aversion at average blood pressure
Interventions/Control_3
Blood abolition at the pressure of mean blood pressure - pulse pressure/2
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
| 39 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing minor dental surgery (surgeries within 4 hours, such as wisdom tooth extraction, jawbone cyst removal, and benign tumor removal) at our dental/oral and oral surgery department. In addition, patients who meet all of the following conditions will be targeted.
1) Target patient age: 20-39 years old
2) Gender: Regardless of gender
3) Past medical history/severity of comorbidities: Those who have been evaluated as Class I or II in the Physical status (ASA-PS classification) defined by the American Society of Anesthesiologists (ASA).
4) Inpatient/Outpatient: All inpatient cases. To check if there are any effects from postoperative studies.
5) Surgery/anesthesia: Surgery completed as planned without requiring blood transfusion due to heavy bleeding.
6)Patients who have received sufficient explanation and informed written consent of their own free will to participate in this study.
Key exclusion criteria
1) Past medical history: Those who have been diagnosed with hypertension, blood disease, hyperlipidemia, or heart disease, whether present or in the past.
2) Oral medications: Those using antihypertensive drugs, blood flow improving drugs, ischemic heart disease treatment drugs, antiplatelet drugs, and anticoagulants. (Patients who had previously stopped taking medication for this surgery are also considered to be on medication)
3) Conditions of the upper arm: Conditions in which it is difficult to avascularize the upper arm.
4) Surgery time: Surgery time exceeds 4 hours.
5) Surgery/anesthesia: Surgery that differed from the planned procedure and required blood transfusion due to massive bleeding.
6) Other patients deemed unsuitable as research subjects by the research director (co-investigator)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Kojima |
Organization
Asahi General Hospital
Division name
Department of anesthesiology
Zip code
25892511
Address
I 1326, Asahi city, Chiba.
TEL
0479638111
cojicoji1109@gmail.com
Public contact
Name of contact person
| 1st name | Yukii |
| Middle name | |
| Last name | Kojima |
Organization
Asahi General Hospital
Division name
Department of Anesthesiology
Zip code
2892511
Address
I 1326, Asahi city, Chiba.
TEL
0479638111
Homepage URL
cojicoji1109@gmail.com
Sponsor or person
Institute
Asahi General Hospital
Institute
Department
Personal name
Funding Source
Organization
Asahi General Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahi Chuo Medical Hospital Ethics Review Committee
Address
I 1326, Asahi city, Chiba.
Tel
0479638111
agh060435@hospital.asahi.chiba.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2023011154
Org. issuing International ID_1
Asahi General Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2023 | Year | 10 | Month | 17 | Day |
Last modified on
| 2024 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059928
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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