UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046136 |
|---|---|
| Receipt number | R000052582 |
| Scientific Title | Patients' first memories after general anesthesia and the frequency of memories of extubation |
| Date of disclosure of the study information | 2021/11/30 |
| Last modified on | 2023/06/26 16:56:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Patients' first memories after general anesthesia and the frequency of memories of extubation
Acronym
Patients' first memories after general anesthesia and the frequency of memories of extubation
Scientific Title
Patients' first memories after general anesthesia and the frequency of memories of extubation
Scientific Title:Acronym
Patients' first memories after general anesthesia and the frequency of memories of extubation
Region
| Japan |
Condition
Condition
Patients after general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the frequency of patients with stressful memories of extubation after general anesthesia
Basic objectives2
Others
Basic objectives -Others
To investigate the content of the first memories after general anesthesia
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of patients with stressful memories of extubation after general anesthesia
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing general anesthesia at Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Patients who were intubated and extubated in an operating room
Scheduled surgery
Key exclusion criteria
ASA PS3 or higher
Emergency surgery
Patients incapable of communicating after surgery
Patients unable to be questioned about their memories on the day after surgery
Target sample size
840
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Shinoura |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name
Department of Anesthesia
Zip code
113-8677
Address
3-18-22 Honkomagome, Bunkyo-ku,Tokyo
TEL
03-3823-2101
hiroshi_shinoura@tmhp.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Shinoura |
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Division name
Department of Anesthesia
Zip code
113-8677
Address
3-18-22 Honkomagome, Bunkyo-ku,Tokyo
TEL
03-3823-2101
Homepage URL
hiroshi_shinoura@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
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
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Address
3-18-22 Honkomagome, Bunkyo-ku,Tokyo
Tel
03-3823-2101
rinri@cick.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 | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.bjaopen.org/article/S2772-6096(23)00026-6/fulltext
Number of participants that the trial has enrolled
818
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 | 11 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Investigating the frequency of patients with stressful memories of extubation after general anesthesia
Investigating the content of the first memory after general anesthesia
Management information
Registered date
| 2021 | Year | 11 | Month | 22 | Day |
Last modified on
| 2023 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052582
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
