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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039271
Receipt No. 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 2020/01/27

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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
Email 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
Email takasusu@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2020 Year 01 Month 26 Day
Date of IRB
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
2020 Year 01 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044788

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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