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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000048138
Receipt No. R000054856
Scientific Title The impact of electric surgical devices on neuromuscular monitoring using TetraGraph.
Date of disclosure of the study information 2022/06/23
Last modified on 2022/06/23

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Basic information
Public title The impact of electric surgical devices on neuromuscular monitoring using TetraGraph.
Acronym The impact of electric surgical devices on neuromuscular monitoring using TetraGraph.
Scientific Title The impact of electric surgical devices on neuromuscular monitoring using TetraGraph.
Scientific Title:Acronym The impact of electric surgical devices on neuromuscular monitoring using TetraGraph.
Region
Japan

Condition
Condition Patients receiving abdominal surgery under general anesthesia.
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Obsterics and gynecology Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the impact of electric surgical devices on neuromuscular monitoring using TetraGraph.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Percentage of incapable measurement with TetraGraph
Key secondary outcomes

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
65 years-old >
Gender Male and Female
Key inclusion criteria Patients with ASA classification 1-3
Patients consented to participate in this study
Key exclusion criteria Patients with ASA classification 4-6
Patients with neuromuscular diseases
Patients with obesity (BMI over or equal to 30)
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Hajime
Middle name
Last name Iwasaki
Organization Asahikawa Medical University
Division name Department of Anesthesiology and Critical Care Medicine
Zip code 078-8510
Address 2-1-1-1 Midorigaoka-higashi, Asahikawa, Hokkaido, Japan
TEL 0166-68-2583
Email iwasakih@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name Hajime
Middle name
Last name Iwasaki
Organization Asahikawa Medical University
Division name Department of Anesthesiology and Critical Care Medicine
Zip code 078-8510
Address 2-1-1-1 Midorigaoka-higashi, Asahikawa, Hokkaido, Japan
TEL 0166-68-2583
Homepage URL
Email iwasakih@asahikawa-med.ac.jp

Sponsor
Institute Asahikawa Medical University
Institute
Department

Funding Source
Organization There is no funding.
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Asahikawa Medical University Research Ethics Committee
Address 2-1-1-1 Midorigaoka-higashi, Asahikawa, Hokkaido, Japan
Tel 0166-68-2187
Email sho-kenkyu@jimu.asahikawa-med.ac.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
2022 Year 06 Month 23 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 Open public recruiting
Date of protocol fixation
2022 Year 05 Month 25 Day
Date of IRB
2022 Year 06 Month 10 Day
Anticipated trial start date
2022 Year 06 Month 23 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Secondary outcomes:
Rate of false detection
Number of continuous unable measurement
Train-of-four (TOF) ratio after calibration
final TOF ratio

Management information
Registered date
2022 Year 06 Month 23 Day
Last modified on
2022 Year 06 Month 23 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054856

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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