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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000010858
Receipt No. 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 2013/06/03

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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&#174; 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
Email

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
Email

Sponsor
Institute Tokyo Metropolitan Health and Medical Treatment Corporation Toshima Hospital.
Department of Anesthesia.
Institute
Department

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
Email

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 Preinitiation
Date of protocol fixation
2013 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 07 Day
Last follow-up date
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
2013 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012710

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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