UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012313
Receipt number R000014399
Scientific Title The study about appropriate infusion rate of rocuronium under geneal anesthesia.
Date of disclosure of the study information 2013/11/18
Last modified on 2016/05/18 11:10:07

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Basic information

Public title

The study about appropriate infusion rate of rocuronium under geneal anesthesia.

Acronym

The study about appropriate infusion rate of rocuronium under geneal anesthesia.

Scientific Title

The study about appropriate infusion rate of rocuronium under geneal anesthesia.

Scientific Title:Acronym

The study about appropriate infusion rate of rocuronium under geneal anesthesia.

Region

Japan


Condition

Condition

general anesthesia

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We will clarify the appropriate infusion rate of rocuronium under general anesthesia by calucutating effective compartment concentraions.

Basic objectives2

PK,PD

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Train of four ratio during surgery

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Medicine

Interventions/Control_1

continuous intravenous infusion of rocuronium

Interventions/Control_2


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

20 years-old <

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

patients receiving surgery under general anesthesia

Key exclusion criteria

patients with impaired liver function
patients with impaired renal function

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Moriyama Takahiro

Organization

Kagoshima university

Division name

Department of anesthesiology

Zip code


Address

8-35-1 Sakuragaoka Kagoshima city

TEL

099-275-5111

Email

takmor@m3.kufm.kagoshima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Moriyama Takahiro

Organization

Kagoshima university

Division name

Department of anesthesiology

Zip code


Address

8-35-1 Sakuragaoka Kagoshima city

TEL

099-275-5111

Homepage URL


Email

takmor@m3.kufm.kagoshima-u.ac.jp


Sponsor or person

Institute

Department of anesthesiology, Kagoshima university hospital

Institute

Department

Personal name



Funding Source

Organization

Department of anesthesiology, Kagoshima 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

2013 Year 11 Month 18 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2013 Year 10 Month 20 Day

Date of IRB


Anticipated trial start date

2013 Year 11 Month 18 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 11 Month 15 Day

Last modified on

2016 Year 05 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014399


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name