UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046549 |
|---|---|
| Receipt number | R000053075 |
| Scientific Title | Prolonged Emergence from General Anesthesia with Remimazolam; Retrospective Observational Study |
| Date of disclosure of the study information | 2022/01/05 |
| Last modified on | 2022/01/05 14:25:50 |
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Basic information
Public title
Prolonged Emergence from General Anesthesia with Remimazolam; Retrospective Observational Study
Acronym
Prolonged Emergence from General Anesthesia with Remimazolam; Retrospective Observational Study
Scientific Title
Prolonged Emergence from General Anesthesia with Remimazolam; Retrospective Observational Study
Scientific Title:Acronym
Prolonged Emergence from General Anesthesia with Remimazolam; Retrospective Observational Study
Region
| Japan |
Condition
Condition
patients undergoing elective surgery under general anesthesia with remimazolam
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze the cause of prolonged recovery from general anesthesia with remimazolam: retrospective study
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
predictive plasma concentrations of remimazolam at the end of remimazolam infusion and upon at the extubation, the total dose of remimazolam
Key secondary outcomes
age, sex, height, body weight, body mass index (BMI), plasma albumin concentration, ASA class, duration of surgery, and total duration of general anesthesia
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
| 15 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients undergoing elective surgery under general anesthesia with remimazolam
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Shimamoto |
Organization
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Division name
Department of Anesthesiology
Zip code
737-0023
Address
3-1 Aoyama, Kure, Hiroshima, Japan
TEL
0823-22-3111
j036eb@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Michiyoshi |
| Middle name | |
| Last name | Sanuki |
Organization
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Division name
Department of Anesthesiology
Zip code
737-0023
Address
3-1 Aoyama, Kure, Hiroshima, Japan
TEL
0823-22-3111
Homepage URL
msanuki@ff.iij4u.or.jp
Sponsor or person
Institute
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board at Kure Medical Center
Address
3-1,Aoyama,Kure,Hiroshima,Japan
Tel
0823223111
yokoo.reina.gs@mail.hosp.go.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
| 2022 | Year | 01 | Month | 05 | 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
65
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
| 2020 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 04 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective study
Management information
Registered date
| 2022 | Year | 01 | Month | 05 | Day |
Last modified on
| 2022 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053075
