UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052659 |
|---|---|
| Receipt number | R000060088 |
| Scientific Title | Effect of Flumazenil on Postoperative Memory Retention Time after General Anesthesia with Remimazolam: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2024/10/31 09:14:33 |
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Basic information
Public title
Effect of Flumazenil on Postoperative Memory Retention Time after General Anesthesia with Remimazolam: A Randomized Controlled Trial
Acronym
Effect of Flumazenil on Postoperative Memory Retention Time after General Anesthesia with Remimazolam: A Randomized Controlled Trial
Scientific Title
Effect of Flumazenil on Postoperative Memory Retention Time after General Anesthesia with Remimazolam: A Randomized Controlled Trial
Scientific Title:Acronym
Effect of Flumazenil on Postoperative Memory Retention Time after General Anesthesia with Remimazolam: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Patients scheduled for breast surgery under general anesthesia
Classification by specialty
| Breast surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect on postoperative memory retention with and without flumazenil administration when remimazolam is used as a sedative during general anesthesia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Time for 80% of patients or all patients in each group to be able to memorize. If the patient had no memory of Illustration A 1 hour after leaving the operating room, one more poster (Illustration B) was shown, and 2 hours after leaving the operating room, the patient's memory of Illustration B was checked. If the patient has no memory of Illustration B, one more poster (Illustration C) is shown, and 3 hours after leaving the operating room, the patient's memory of Illustration C is checked. If the patient remembers Illustration C, the evaluation is terminated at that point.
Key secondary outcomes
(1) Percentage of patients whose memory of the poster shown after awakening from anesthesia could be confirmed 1 hour after leaving the operating room.
(2) Dosage and frequency of analgesic use from the time of return to the ward to 3 hours after surgery
(3) Dosage and frequency of antiemetic use from the time of return to the ward to 3 hours after surgery
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is 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
Flumazenil group after general anesthesia
Interventions/Control_2
No flumazenil administered after general anesthesia
group
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
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients who meet all of the following criteria will be eligible
1. the patient has given written consent of his/her own free will
2. age between 20 and 65 years old at the time of consent
3. scheduled to undergo breast surgery under general anesthesia.
Key exclusion criteria
Patients will be excluded from the study if any of the following apply
1) Patients with a history of hypersensitivity to remimazolam or flumazenil
2. patients with acute angle closure glaucoma, myasthenia gravis, epilepsy patients who have been receiving benzodiazepines for a long period of time, or have a history of serious complications or illnesses that would make them inappropriate for participation in this study
Patients who are deemed inappropriate for inclusion in the study by the investigator. 4.
(4) Patients with ASA physical status of IV or higher, shock, or coma (5) Patients with cognitive impairment
5. patients with cognitive impairment
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Shirozu |
Organization
Kyushu University Hospital
Division name
Operating room
Zip code
812-8582
Address
3-1-1 maidashi, higashi-ku, Fukuoka
TEL
092-642-5714
shirozu.kazuhiro.334@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Shirozu |
Organization
Kyushu University Hospital
Division name
Operating room
Zip code
812-8582
Address
3-1-1 maidashi, higashi-ku, Fukuoka
TEL
092-642-5714
Homepage URL
shirozu.kazuhiro.334@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
No external funders are not pertained to this manuscript. Funding is provided by self-funding. There are no external funders associated with this manuscript.
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
Kyushu University certified institutional review board for clinical trial
Address
3-1-1 maidashi, higashi-ku, Fukuoka
Tel
092-642-5774
kyudai-rinri@jimu.kyushu-u.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 | 11 | Month | 01 | 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
Completed
Date of protocol fixation
| 2023 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | 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 | 31 | Day |
Last modified on
| 2024 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060088
