UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014919 |
|---|---|
| Receipt number | 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 20:27:49 |
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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
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
shitaguchi@city.fukuyama.hiroshima.jp
Sponsor or person
Institute
Fukuyama City Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017358
