UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045593 |
|---|---|
| Receipt number | R000052026 |
| Scientific Title | The effect of remimazolam on postoperative memory retention and delayed regeneration in breast surgery patients: Rationale and design of an exploratory, randomized, open, propofol-controlled, single-center clinical trial. |
| Date of disclosure of the study information | 2021/09/28 |
| Last modified on | 2023/07/20 00:05:02 |
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Basic information
Public title
The effect of remimazolam on postoperative memory retention and delayed regeneration in breast surgery patients: Rationale and design of an exploratory, randomized, open, propofol-controlled, single-center clinical trial.
Acronym
effect remimazolam memory retention delayed regeneration (FERMENTER)
Scientific Title
The effect of remimazolam on postoperative memory retention and delayed regeneration in breast surgery patients: Rationale and design of an exploratory, randomized, open, propofol-controlled, single-center clinical trial.
Scientific Title:Acronym
FERMENTER
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
the aim of this study was to compare the effects of different sedative drugs during general anesthesia on memory retention in postoperative patients, and to establish a method to evaluate effects on anterograde amnesia in validation clinical trials.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint examined in this RCT is the assessment of anterograde amnesia.
(1) The number of posters remembered 24 hours after surgery among four posters shown after awakening from anesthesia. Specifically, after awakening from anesthesia and being able to say their names, patients are to be shown four posters.
Key secondary outcomes
(1) The number of events remembered from prior to the start of anesthesia: ambulatory entry, bed transfer, vein insertion, BIS monitor attachment to the forehead, and mask fitting, and based on whether the patient remembers the poster (see Appendix) shown before the induction of anesthesia.
(2) The amount of analgesic medication from the time the patient returns to the ward until 24 h after surgery.
(3) Immediate postoperative pain numerical rating scale (NRS) values (see Appendix).
(4) Pain NRS scores 24 h after leaving the operating room.
Safety endpoints
1) Nausea assessed based on the amount of antiemetic medication used immediately after surgery and from the time of returning to the ward until 24 hours after surgery.
2) Time to full awakening.
3) The incidences of hypotension, bradycardia, rhabdomyolysis, and anaphylaxis.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Remimazolam
Interventions/Control_2
Propofol
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
Male and Female
Key inclusion criteria
The following criteria are necessary in order to meet eligibility requirements for the current study.
(1) Patients must provide written informed consent by their own free will.
(2) Patients must be aged 20 years or older and must be under 65 years of age.
(3) Patients must be undergoing breast surgery under general anesthesia.
Key exclusion criteria
Patients should be excluded if any one of the following criteria apply.
(1) Patients with a history of hypersensitivity to remimazolam or propofol.
(2) Patients with egg or soybean oil allergies, acute angle-closure glaucoma, myasthenia gravis, serious disease complications, or a history of allergies.
(3) Patients with an ASA (American society of anesthesiologists) physical status of IV or higher, shock, or coma.
(4) Patients who are judged as inappropriate for inclusion in the study.
(5) Patients with impaired cognitive function.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Shirozu |
Organization
Kyushu University Hospital
Division name
Anesthesiology
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
Anesthesiology
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
JAPAN
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
| 2021 | Year | 09 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
74
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
| 2021 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 28 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 14 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 14 | Day |
Date analysis concluded
| 2023 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 28 | Day |
Last modified on
| 2023 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052026
