UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007254
Receipt number R000008554
Scientific Title Reversal of rocuronium induced neuromuscular block by sugammadex for electroconvulsive therapy; crossover designed dose response study
Date of disclosure of the study information 2012/02/21
Last modified on 2012/02/09 12:10:47

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Basic information

Public title

Reversal of rocuronium induced neuromuscular block by sugammadex for electroconvulsive therapy; crossover designed dose response study

Acronym

Reversal of rocuronium induced neuromuscular block by sugammadex for electroconvulsive therapy; crossover designed dose response study

Scientific Title

Reversal of rocuronium induced neuromuscular block by sugammadex for electroconvulsive therapy; crossover designed dose response study

Scientific Title:Acronym

Reversal of rocuronium induced neuromuscular block by sugammadex for electroconvulsive therapy; crossover designed dose response study

Region

Japan


Condition

Condition

Psychiatric disease

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study is designed to evaluate muscular relaxant reverse effect of sugammadex for rocuronium.

Basic objectives2

PK,PD

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Reversal effect of sugammadex for rocuronium induced neuromuscular block

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

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

To evaluate dose response muscular blockade reversal effect, 2 mg/kg of sugammadex will be assigned.

Interventions/Control_2

To evaluate dose response muscular blockade reversal effect, 4 mg/kg of sugammadex will be assigned.

Interventions/Control_3

To evaluate dose response muscular blockade reversal effect, 8 mg/kg of sugammadex will be assigned.

Interventions/Control_4

To evaluate dose response muscular blockade reversal effect, 16 mg/kg of sugammadex will be assigned.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients who will be planned electroconvulsive therapy
2. Patients who are capable of providing written informed consent.

Key exclusion criteria

Patients seems inadequate for this study by investigators

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Makoto Ozaki

Organization

Tokyo Women's Medical University Hospital

Division name

Department of Anesthesiology

Zip code


Address

8-1 Kawada-cho Shinjuku-ku, Tokyo

TEL

03-3353-8111

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Tokyo Women's Medical University Hospital

Division name

Department of Anesthesiology

Zip code


Address

8-1 Kawada-cho Shinjuku-ku, Tokyo

TEL


Homepage URL


Email



Sponsor or person

Institute

Tokyo Women's Medical University Hospital

Institute

Department

Personal name



Funding Source

Organization

Tokyo Women's Medical University 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

2012 Year 02 Month 21 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

2012 Year 02 Month 21 Day

Date of IRB


Anticipated trial start date

2012 Year 03 Month 01 Day

Last follow-up date

2014 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 02 Month 09 Day

Last modified on

2012 Year 02 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008554


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name