UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051924 |
|---|---|
| Receipt number | R000059242 |
| Scientific Title | Postoperative anterograde amnesia by remimazolam and antagonism with flumazenil |
| Date of disclosure of the study information | 2023/08/18 |
| Last modified on | 2023/12/14 13:51:57 |
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Basic information
Public title
Postoperative anterograde amnesia by remimazolam and antagonism with flumazenil
Acronym
Postoperative anterograde amnesia by remimazolam and antagonism with flumazenil
Scientific Title
Postoperative anterograde amnesia by remimazolam and antagonism with flumazenil
Scientific Title:Acronym
Postoperative anterograde amnesia by remimazolam and antagonism with flumazenil
Region
| Japan |
Condition
Condition
Patients who will undergo general anesthesia for elective surgery of lower limbs
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the antagonism effect of flumazenil to anterograde amnesia of remimazolam
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of memory test by flumazenil
Key secondary outcomes
Time course of the score in memory test, Incidence of retrograde amnesia/ postoperative delirium/ postoperative sleep disorder
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administration of flumazenil
Interventions/Control_2
administration of normal saline (placebo)
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Adult patient who will undergo elective surgery
(2) Age 20-75
(3) No gender restriction
(4) Patients who manifest consent for this study
Key exclusion criteria
(1) Patients contraindicate or with allergy to remimazolam or flumazenil
(2) Patients contraindicate to neuraxial block
(3) Patients with cognitive impairment
(4) Patients with intracranial disease or cerebrovascular disease
(5) Patients who take psychiatric medication
(6) Patients who usually take benzodiazepine
(7) ASAPS 3 or 4
(8) Patients decided not to be eligible for this study
(9) Patients administrated flumazenil for clinical reason (not for research protocol)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kotoe |
| Middle name | |
| Last name | Kamata |
Organization
Tohoku University Hospital
Division name
Department of Anesthesiology
Zip code
980-8575
Address
2-1, Seiryomachi, Aobaku, Sendai, Miyagi, 980-8575, Japan
TEL
022-717-7321
mattytohoku@gmail.com
Public contact
Name of contact person
| 1st name | Kotoe |
| Middle name | |
| Last name | Kamata |
Organization
Tohoku University Hospital
Division name
Department of Anesthisiology
Zip code
980-8575
Address
2-1, Seiryomachi, Aobaku, Sendai, Miyagi, 980-8575, Japan
TEL
022-717-7321
Homepage URL
mattytohoku@gmail.com
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
No funding sourse
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
1-1, Seiryomachi, Aobaku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2023 | Year | 08 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 08 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 12 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 30 | 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 | 08 | Month | 16 | Day |
Last modified on
| 2023 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059242
