UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010858 |
|---|---|
| Receipt number | R000012710 |
| Scientific Title | The efficacy of remifentanil on the BIS values of patients who are treated with mECT:open-labeled single center non-randomized cross-over trial |
| Date of disclosure of the study information | 2013/06/04 |
| Last modified on | 2021/12/09 17:23:10 |
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Basic information
Public title
The efficacy of remifentanil on the BIS values of patients who are treated with mECT:open-labeled single center non-randomized cross-over trial
Acronym
The efficacy of remifentanil on the BIS values of patients who are treated with mECT
Scientific Title
The efficacy of remifentanil on the BIS values of patients who are treated with mECT:open-labeled single center non-randomized cross-over trial
Scientific Title:Acronym
The efficacy of remifentanil on the BIS values of patients who are treated with mECT
Region
| Japan |
Condition
Condition
Psychiatric disorders
Classification by specialty
| Psychiatry | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the modified electroconvulsive therapy (mECT), shallow sedation leads to intraoperative memory, whereas deep sedation leads to insufficient convulsion. With remifentanil , of which anti-convulsive effect is small, we examine whether patients are sedated deeper than those treated with the conventional treatment, and sedated with no effect on the convulsion duration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
the BIS value before the electrical stimulus,
the duration of the convulsion
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In the interventional treatments, patients are sedated with remifentanil 1mcg/kg in addition to thiopental 3mg/kg.
Interventions/Control_2
In the control treatments, patients are sedated with thiopental 3mg/kg.
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The study population consists of patients whose BIS values before the electrical stimuli are more than 60, when they are treated with Thymatron® for the first time.
Key exclusion criteria
ASA PS 4 or 5
history of ischemic heart disease
history of heart disease as harmful as ischemic disease
allergies or contraindications to medications used in the trial
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Shinozaki |
Organization
Tokyo Metropolitan Health and Medical Treatment Corporation Toshima Hospital.
Division name
Department of Anesthesia
Zip code
Address
33-1 Sakaecho,Itabashi-Ku,Tokyo
TEL
03-5375-1234
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokyo Metropolitan Health and Medical Treatment Corporation Toshima Hospital.
Division name
Department of Anesthesia
Zip code
Address
33-1 Sakaecho,Itabashi-Ku,Tokyo
TEL
03-5375-1234
Homepage URL
Sponsor or person
Institute
Tokyo Metropolitan Health and Medical Treatment Corporation Toshima Hospital.
Department of Anesthesia.
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Health and Medical Treatment Corporation Toshima 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
Address
Tel
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
| 2013 | Year | 06 | Month | 04 | 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
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
| 2013 | Year | 05 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 03 | Day |
Last modified on
| 2021 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012710
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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