UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033378 |
|---|---|
| Receipt number | R000038057 |
| Scientific Title | Efficacy and safety of propofol administration with esTEC, a pharmacodynamic index. |
| Date of disclosure of the study information | 2023/03/31 |
| Last modified on | 2024/04/29 09:52:01 |
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Basic information
Public title
Efficacy and safety of propofol administration with esTEC, a pharmacodynamic index.
Acronym
Propofol administration with esTEC
Scientific Title
Efficacy and safety of propofol administration with esTEC, a pharmacodynamic index.
Scientific Title:Acronym
Propofol administration with esTEC
Region
| Japan |
Condition
Condition
Adult patients scheduled for an elective surgery requiring general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we aim to investigate the uefficacy and safety of propofol administration with esTEC, a pharmacodynamic index.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
average BIS value, the percentage of time with BIS between 35 and 55, the percentage of time with BIS >55,the percentage of time with BIS <35, burst suppression ratio, Blood pressure and pulse fluctuation,time to tracheal extubatuion, drugs consumption
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
esTEC control group
Interventions/Control_2
manual 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
| 15 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for elective surgery requiring general anesthesia
Key exclusion criteria
Patients with general anestheisia with nerve block and epidural anesthesia
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Matsuki |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Department of Anaesthesiology & Reanimatology
Zip code
910-1193
Address
23-3 Eiheijicho, Yoshidagun, Fukui 910-1193, Japan
TEL
0776618391
ymatsuki@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Matsuki |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Department of Anaesthesiology & Reanimatology
Zip code
910-1193
Address
23-3 Eiheijicho, Yoshidagun, Fukui 910-1193, Japan
TEL
0776618391
Homepage URL
ymatsuki@u-fukui.ac.jp
Sponsor or person
Institute
Faculty of Medical Sciences, University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Faculty of Medical Sciences, University of Fukui
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
Faculty of Medical Sciences, University of Fukui
Address
23-3 Eiheijicho, Yoshidagun, Fukui 910-1193, Japan
Tel
0776-61-8529
rinsho-rinri@ml.u-fukui.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 | 03 | Month | 31 | 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
40
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
Terminated
Date of protocol fixation
| 2017 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 13 | Day |
Last modified on
| 2024 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038057
