UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035029
Receipt number R000039929
Scientific Title Simultaneous administration of intubating doses of both rocuronium and suxamethonium reduces suxamethonium-induced fasciculations
Date of disclosure of the study information 2018/11/27
Last modified on 2020/05/29 09:14:10

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Basic information

Public title

Simultaneous administration of intubating doses of both rocuronium and suxamethonium reduces suxamethonium-induced fasciculations

Acronym

A new approach for preventing suxamethonium-induced fasciculations

Scientific Title

Simultaneous administration of intubating doses of both rocuronium and suxamethonium reduces suxamethonium-induced fasciculations

Scientific Title:Acronym

A new approach for preventing suxamethonium-induced fasciculations

Region

Japan


Condition

Condition

Suxamethonium-induced fasciculation

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Effect of simultaneous administration of intubating doses of both rocuronium and suxamethonium on suxamethonium-induced fasciculations

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

intensity of fasciculation

Key secondary outcomes

intubating condition


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

85 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients for elective non-obstetric surgery requiring general anesthesia with endotracheal intubation

Key exclusion criteria

Patients classified as American Society of Anesthesiologists physical status 3-5 with body mass index of more than 30 kg m-2, cervical spine abnormality, pharyngolaryngeal pathology, anticipated difficult airway, an increased risk of aspiration, and contraindication of suxamethonium

Target sample size

34


Research contact person

Name of lead principal investigator

1st name Ichiro
Middle name
Last name Takenaka

Organization

Japan Organization of Occupational Health and Safety Kyushu Rosai Hospital

Division name

Department of Anesthesia

Zip code

8000296

Address

1-1 Sonekitamachi Kokuraminami Kitakyushu Fukuoka

TEL

0934711121

Email

dd6xj6rx7@yahoo.co.jp


Public contact

Name of contact person

1st name Ichiro
Middle name
Last name Takenaka

Organization

Japan Organization of Occupational Health and Safety Kyushu Rosai Hospital

Division name

Department of Anesthesia

Zip code

8000296

Address

1-1 Sonekitamachi Kokuraminami Kitakyushu Fukuoka

TEL

81934711121

Homepage URL


Email

dd6xj6rx7@yahoo.co.jp


Sponsor or person

Institute

Japan Organization of Occupational Health and Safety Kyushu Rosai Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan Organization of Occupational Health and Safety Kyushu Rosai Hospital

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Japan Organization of Occupational Health and Safety Kyushu Rosai Hospital

Address

1-1 Sonekita-machi Kokuraminami Kitakyushu Japan

Tel

81934711121

Email

syomuka.geaf@kyushuh.johas.go.jp


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

2018 Year 11 Month 27 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 11 Month 27 Day

Date of IRB


Anticipated trial start date

2018 Year 11 Month 27 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

nothing particular


Management information

Registered date

2018 Year 11 Month 27 Day

Last modified on

2020 Year 05 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039929


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name