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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014919
Receipt No. R000017358
Scientific Title Effect of lung protective ventilation-induced respiratory acidosis on neuromuscular block by rocuronium
Date of disclosure of the study information 2014/08/31
Last modified on 2015/08/31

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Basic information
Public title Effect of lung protective ventilation-induced respiratory acidosis on neuromuscular block by rocuronium
Acronym Effect of respiratory acidosis on neuromuscular block by rocuronium
Scientific Title Effect of lung protective ventilation-induced respiratory acidosis on neuromuscular block by rocuronium
Scientific Title:Acronym Effect of respiratory acidosis on neuromuscular block by rocuronium
Region
Japan

Condition
Condition patients undergoing elective surgery under general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to determine whether respiratory acidosis affects duration of neuromuscular block by rocuronium
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes duration of neuromuscular block by rocuronium
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 lung protective ventilation
Interventions/Control_2 traditional ventilation
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
79 years-old >=
Gender Male and Female
Key inclusion criteria inclusion criteria are ASA-PS 1-2 cases with normal respiratory, renal and liver functions and with body mass index (BMI) between 19 and 28
Key exclusion criteria Patients who were associated with neuromuscular disease or who were taking medications known to interact with muscle relaxants
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinya Taguchi
Organization Fukuyama City Hospital
Division name Department of Anesthesiology and Oncological Pain Medicine
Zip code
Address 5-23-1, Zao-cho, Fukuyama city, Hiroshima 721-8511, JAPAN
TEL 084-941-5151
Email shitaguchi@city.fukuyama.hiroshima.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinya Taguchi
Organization Fukuyama City Hospital
Division name Department of Anesthesiology and Oncological Pain Medicine
Zip code
Address 5-23-1, Zao-cho, Fukuyama city, Hiroshima 721-8511, JAPAN
TEL 084-941-5151
Homepage URL
Email shitaguchi@city.fukuyama.hiroshima.jp

Sponsor
Institute Fukuyama City Hospital
Institute
Department

Funding Source
Organization none
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
2014 Year 08 Month 31 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
2014 Year 08 Month 21 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 01 Day
Last follow-up date
2015 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 08 Month 21 Day
Last modified on
2015 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017358

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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