UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034513 |
|---|---|
| Receipt number | R000039352 |
| Scientific Title | Establishment of new wakefulness judgment method applying eye movement measurement after intravenous sedation method adjustment. |
| Date of disclosure of the study information | 2019/04/02 |
| Last modified on | 2022/10/18 22:19:43 |
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Basic information
Public title
Establishment of new wakefulness judgment method applying eye movement measurement after intravenous sedation method adjustment.
Acronym
New arousal judgment method applying eye movement measurement.
Scientific Title
Establishment of new wakefulness judgment method applying eye movement measurement after intravenous sedation method adjustment.
Scientific Title:Acronym
New arousal judgment method applying eye movement measurement.
Region
| Japan |
Condition
Condition
Patient after sedation law.(Healthy adult)
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between eye movement and EEG during awake.
We aim to secure the new awake judgment method.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. eye movement
2. EEG signal (BIS value)
3. Romberg test
4. clinical findings
5. Sedation score
Measure at intervals of 30 minutes after completion of treatment by sedation.
Measure up to 120 minutes after the end of the sedation method.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
After intravenous sedation with midazolam is performed, the arousal state is evaluated without administration of the antagonist.
Physiological saline was administered instead of antagonist.
Interventions/Control_2
After intravenous sedation with midazolam is administered, an antagonist(Flumazenil) is administered to evaluate the arousal state.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adult
Key exclusion criteria
Patients with high blood pressure and systemic diseases such as diabetes
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yosihide |
| Middle name | |
| Last name | Saitou |
Organization
The Nippon dental University Niigata Hospital
Division name
Dental Anesthesia / Systemic management Department
Zip code
951-8580
Address
1-8 Hamaura-cho, Chuo-ku, Niigata
TEL
025-211-8212
sai10yo@ngt.ndu.ac.jp
Public contact
Name of contact person
| 1st name | Yosihide |
| Middle name | |
| Last name | Saitou |
Organization
The Nippon dental University Niigata Hospital
Division name
Dental Anesthesia / Systemic management Department
Zip code
951-8580
Address
1-8 Hamaura-cho, Chuo-ku, Niigata
TEL
025-211-8212
Homepage URL
sai10yo@ngt.ndu.ac.jp
Sponsor or person
Institute
The Nippon dental University Niigata Hospital
Institute
Department
Personal name
Funding Source
Organization
Self-sourcing
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
The Nippon dental University Niigata Hospital
Address
1-8 Hamaura-cho, Chuo-ku, Niigata
Tel
025-211-8212
sai10yo@ngt.ndu.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
| 2019 | Year | 04 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 15 | Day |
Last modified on
| 2022 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039352
