UMIN-CTR Clinical Trial

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

Major depressive disorder, Schizophrenia, Bipolar disorder

Classification by specialty

Psychiatry

Anesthesiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

none

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大阪大学医学部附属病院麻酔科

Date of disclosure of the study information

2016

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

01

Month

26

Day

Last modified on

2018

Year

08

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023819