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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020746
Receipt No. R000023819
Scientific Title The safety and efficacy of Desflurane for modified electrical convulsive therapy
Date of disclosure of the study information 2016/04/01
Last modified on 2018/08/15

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Basic information
Public title The safety and efficacy of Desflurane for modified electrical convulsive therapy
Acronym The safety and efficacy of Desflurane for modified electrical convulsive therapy
Scientific Title The safety and efficacy of Desflurane for modified electrical convulsive therapy
Scientific Title:Acronym The safety and efficacy of Desflurane for modified electrical convulsive therapy
Region
Japan

Condition
Condition Major depressive disorder, Schizophrenia, Bipolar disorder
Classification by specialty
Psychiatry Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We will analyze the safety and efficacy of the use of Desflurane for general anesthesia management compared to Propofol during modified electric convulsive therapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The time for full recovery after modified electric convulsive therapy.
Key secondary outcomes Outcomes measured during each session
1) Heart rate, blood pressure, Bispectical Index during general anesthesia
2) Cumulative EEG duration, Visual seizure duration
Outcomes measured at time points of the physician's discretion
1) PANSS
2) HAM-D
3) Global Assessment of Functioning
4) Clinical Global Impression of Change
5) Mini Mental State Examination

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Desflurane is used for the first to 5th modified electroconvulsive therapy (mECT) session and Propofol is used for the 6th to 10 mECT session
Interventions/Control_2 Propofol is used for the first to 5th mECT session and Desflurane is used for the 6th to 10 mECT session
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Inpatients at the University of Osaka Hospital whom are scheduled for modified electroconvulsive therapy (mECT) with the diagnosis for either major depression, schizophrenia, or bipolar disorder are asked to participate in the study.
2) Patients whom are over the age of 16 and are able to fully understand the terms and conditions of the study are eligible.
3) Patients whom have given informed consent to volunteer to enter this trial
Key exclusion criteria 1) Patients unable to give informed consent to volunteer for this trial
2) When mECT is contraindicated
Absolute contraindications: Known pheochromocytoma
Relative contraindications: increased intracranial pressure, brain tumors, recent stroke, cardiovascular conduction defects, high-risk pregnancy, aortic and cerebral aneurysms, and Asthma
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sho C. Shibata
Organization Graduate School of Medicine, Osaka University
Division name Department of Anesthesiology and Intensive Care Medicine
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL +81668793133
Email karlshibata@pain.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sho C. Shibata
Organization Graduate School of Medicine, Osaka University
Division name Department of Anesthesiology and Intensive Care Medicine
Zip code
Address 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan
TEL +81668793133
Homepage URL http://www.med.osaka-u.ac.jp/pub/anes/www/html/masui-kouza/clinical_research/index.html
Email karlshibata@pain.med.osaka-u.ac.jp

Sponsor
Institute Department of Anesthesiology and Intensive Care Medicine, Graduate School of Medicine, Osaka University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor none
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 大阪大学医学部附属病院麻酔科

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 01 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
2018 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 15 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
2016 Year 01 Month 26 Day
Last modified on
2018 Year 08 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023819

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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