UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045998 |
|---|---|
| Receipt number | R000050614 |
| Scientific Title | The cardiac electrophysiological effects and the investigation on the incidence of post-operative cognitive dysfunction (POCD) on using of Remimazolam. (a retrospective-test) |
| Date of disclosure of the study information | 2021/11/09 |
| Last modified on | 2024/08/26 12:45:57 |
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Basic information
Public title
Effects on various organs in patients who used Remimazolam under general anesthesia
Acronym
Effects of Remimazolam on various organs
Scientific Title
The cardiac electrophysiological effects and the investigation on the incidence of post-operative cognitive dysfunction (POCD) on using of Remimazolam. (a retrospective-test)
Scientific Title:Acronym
The cardiac electrophysiological effects and the investigation on the incidence of post-operative cognitive dysfunction (POCD) on using of Remimazolam. (a retrospective-test)
Region
| Japan |
Condition
Condition
All patients under general anesthesia
Classification by specialty
| Surgery in general | Ophthalmology | Oto-rhino-laryngology |
| Anesthesiology | Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analyzing heart rate variability due to Remimazolam and propofol
Investigation of the incidence of postoperative delirium with anesthetics
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Heart rate variability
Key secondary outcomes
Circulatory dynamics (vital signs)
POD / POCD incidence
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who underwent general anesthesia using Remimazolam or Propofol at our hospital, regardless of gender.
2) Patients who underwent artificial respiration management by tracheal intubation, etc.
Key exclusion criteria
1) Cases using "excluded drugs"
2) Patients under the age of 20 at the time of obtaining the comprehensive consent form
3) Patients with AST (GOT) or ALT (GPT) of 100 IU / L or higher in general preoperative laboratory tests
4) Patients with Child-Pugh classification B or C
5) Patients with serum creatinine of 2.0 mg / dL or higher in general preoperative laboratory tests
6) Patients who have been using benzodiazepines for a long time
7) When there is a possibility that EEG and BIS values cannot be measured properly due to organic abnormalities in the brain or other surgical procedures.
8) Patients who underwent epidural anesthesia / spinal anesthesia
(Because it may be affected by local anesthesia or premedication)
9) Patients with cardiac pacemakers and ICDs (because they are not suitable for electrocardiogram analysis)
10) The research subject has declared his intention to refuse by oral writing.
11) Other patients judged to be inappropriate by the principal investigator
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Shota |
| Middle name | |
| Last name | Tsukimoto |
Organization
Kindai university
Division name
Department of Anesthesiology
Zip code
5898511
Address
377-2, Onohigashi, Osaka-sayama, Osaka, Japan
TEL
072-366-0221
s-tsukimoto@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Tsukimoto |
Organization
Kindai University
Division name
Department of Anesthesiology
Zip code
5898511
Address
377-2, Onohigashi, Osaka-sayama, Osaka, Japan
TEL
072-366-0221
Homepage URL
s-tsukimoto@med.kindai.ac.jp
Sponsor or person
Institute
Kindai university faculty of medicine
Institute
Department
Personal name
Funding Source
Organization
Self-funding and individual research expenses
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
Kindai university faculty of medicine of Ethics Committe
Address
377-2, Onohigashi, Osaka-sayama, Osaka, Japan
Tel
072-366-0221
zizen@med.kindai.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 | 11 | Month | 09 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
100
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
I think that further results analysis is needed.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
none
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
July.31.2023 Some errors have been corrected.
April 15, 2024 The results of the study were reported in a paper (DOI: https://doi.org/10.7759/cureus.58340.).
Management information
Registered date
| 2021 | Year | 11 | Month | 06 | 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=R000050614
