UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022300
Receipt number R000025693
Scientific Title Assessment of the reduced injection pain of the newly developed formation of the rocuronium
Date of disclosure of the study information 2016/05/20
Last modified on 2018/11/14 13:56:53

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Basic information

Public title

Assessment of the reduced injection pain of the newly developed formation of the rocuronium

Acronym

Assessment of injection pain of rocuronium

Scientific Title

Assessment of the reduced injection pain of the newly developed formation of the rocuronium

Scientific Title:Acronym

Assessment of injection pain of rocuronium

Region

Japan


Condition

Condition

Patients requiring general anesthesia

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We will investigate injection associated pain will be reduced in newly developed formula of roculonium, comparing to the eslax, currently available formula of roculonium. Primary outcome will be a frequency of the withdrawal response of upper arm 3 minutes after the drug injection. Secondary outcomes will be the magnitude of the withdrawal response, change of blood pressure and heart rate.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

frequency of the withdrawal response of upper arm 3 minutes after the drug injection.

Key secondary outcomes

magnitude of the withdrawal response, change of blood pressure and heart rate 3 minutes after the drug injection.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

After the induction of general anesthesia, newly developed form of roculonium (0.9mg/Kg) will be injected intravenously.

Interventions/Control_2

After the induction of general anesthesia, eslax (0.9mg/Kg) will be injected intravenously.

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

1 years-old <=

Age-upper limit

65 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients who will receive elective surgery under general anesthesia and obtained written informed consent about this study.

Key exclusion criteria

Muscular disease
Known allergy against eslax, propofol
Muscle weakness of upper arm
Obesity (BMI>30%)

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Fumimasa Amaya

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Anesthesiology

Zip code


Address

Kajiicho 465 Kamigyo-ku Kyoto

TEL

075-251-5633

Email

ama@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Fumimasa Amaya

Organization

Kyoto Prefectural University of Medicine

Division name

Department of Anesthesiology

Zip code


Address

Kajiicho 465 Kamigyo-ku Kyoto

TEL

075-251-5633

Homepage URL


Email

ama@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Maruishi Pharmaceutical Co.Ltd
Fuji Phrama Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

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

2016 Year 05 Month 20 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

Completed

Date of protocol fixation

2016 Year 05 Month 11 Day

Date of IRB


Anticipated trial start date

2017 Year 08 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

2016 Year 05 Month 13 Day

Last modified on

2018 Year 11 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025693


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name