UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039271 |
|---|---|
| Receipt number | R000044788 |
| Scientific Title | Effects of remifentanil on change of cardiac autonomic nerve system during modified electroconvulsive therapy |
| Date of disclosure of the study information | 2020/01/27 |
| Last modified on | 2023/08/04 09:59:16 |
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Basic information
Public title
Effects of remifentanil on change of cardiac autonomic nerve system during modified electroconvulsive therapy
Acronym
Remifentanil and modified electroconvulsive therapy
Scientific Title
Effects of remifentanil on change of cardiac autonomic nerve system during modified electroconvulsive therapy
Scientific Title:Acronym
Remifentanil and modified electroconvulsive therapy
Region
| Japan |
Condition
Condition
Depression and schizophrenia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effects of remifentanil on cardiovascular systems, we measure the LF/HF as an index of autonomic activity change during electroconvulsive therapy (mECT).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of LF/HF(low-frequency/high-frequency) during mECT.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Remifentanil 0.5micrograms/kg i.v. before mECT
Interventions/Control_2
Remifentanil 1microgams/kg i.v. before mECT
Interventions/Control_3
Control group
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients scheduled to undergo mECT under general anesthesia after obtaining the written informed consent.
Key exclusion criteria
Patients with cardiovascular didease
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shigeki |
| Middle name | |
| Last name | Yamaguchi |
Organization
Dokkyo Medical University
Division name
Department of Anesthesiology
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Tochigi, Japan
TEL
0282-86-1111
takasusu@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Toshifumi |
| Middle name | |
| Last name | Takasusuki |
Organization
Dokkyo Medical University
Division name
Department of Anesthesiology
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Tochigi, Japan
TEL
0282-86-1111
Homepage URL
takasusu@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University
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
Dokkyo Medical University
Address
880 Kitakobayashi, Mibu, Tochigi, Japan
Tel
0282-86-1111
takasusu@dokkyomed.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
| 2020 | Year | 01 | Month | 27 | 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
Main results already published
Date of protocol fixation
| 2020 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 27 | Day |
Last modified on
| 2023 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044788
