UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054972 |
|---|---|
| Receipt number | R000062810 |
| Scientific Title | How Cerebral Tissue Oxygen Saturation is Altered by Retroflexion and Head Rotation in General Anesthesia. |
| Date of disclosure of the study information | 2024/07/16 |
| Last modified on | 2024/08/26 12:42:33 |
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Basic information
Public title
Effects of Anesthetic Drugs and Head Position Changes on Cerebral Tissue Oxygen Saturation in General Anesthesia.
Acronym
To determine the effect of anesthetics on surgical position (head position) in General Anesthesia.
Scientific Title
How Cerebral Tissue Oxygen Saturation is Altered by Retroflexion and Head Rotation in General Anesthesia.
Scientific Title:Acronym
Effects of head retroflexion and head rotation on cerebral tissue oxygen saturation
Region
| Japan |
Condition
Condition
Men and women over 20 years old scheduled for oral surgery under general anesthesia at Kanagawa Dental University Hospital.
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of head retroflexion and head rotation on cerebral tissue oxygen saturation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of change in Tissue Oxygen Index.
In situations where near-infrared spectroscopy is used on brain tissue, tissue oxygen index and brain tissue oxygen saturation are synonymous.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Use of inhaled anesthetic agents in the maintenance of general anesthesia.
Interventions/Control_2
Use of Propofol in the maintenance of general anesthesia.
Interventions/Control_3
Use of Remimazolam in the maintenance of general anesthesia.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Men and women over 20 years old scheduled for oral surgery under general anesthesia at Kanagawa Dental University Hospital.
Key exclusion criteria
1. an ASA-PS of 3 or higher
2. blood samples taken prior to the preoperative visit that meet the following criteria
AST (GOT) or ALT (GPT) greater than 100 IU/L
Serum creatinine > 2.0 mg/dL
HbA1c greater than or equal to 7.5
3. taking benzodiazepines for more than 1 year
4. whose EEG and BIS values may not be properly measured (including vascular lesions)
5. those with a cardiac pacemaker or ICD
6. who have expressed (including verbally) their refusal to participate in this study
7. other subjects deemed inappropriate by the principal investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shota |
| Middle name | |
| Last name | Tsukimoto |
Organization
Kanagawa Dental University
Division name
Department of Anesthesiology
Zip code
238-8570
Address
1-23, Ogawa-cho, Yokosuka, Kanagawa
TEL
046-822-8810
tsukimoto@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Tsukimoto |
Organization
Kanagawa dental university
Division name
Department of dental anesthesiology
Zip code
238-8570
Address
1-23, Ogawa-cho, Yokosuka, Kanagawa
TEL
046-822-8810
Homepage URL
https://www.kdu.ac.jp/hospital/department/dental/anesthesiology/
tsukimoto@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
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
Kanagawad Dental University
Address
82, Inaoka-cho, Yokosuka, Kanagawa, Japan
Tel
046-822-8810
kenkyo@kdu.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
| 2024 | Year | 07 | Month | 16 | Day |
Related information
URL releasing protocol
https://www.kdu.ac.jp/hospital/department/dental/anesthesiology/
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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
July 16, 2024: The start of research implementation has been delayed due to the time required to procure equipment.
Management information
Registered date
| 2024 | Year | 07 | Month | 16 | Day |
Last modified on
| 2024 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062810
