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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040272
Receipt No. R000045943
Scientific Title impact on continuous acceleromyography use for intraoperative period
Date of disclosure of the study information 2020/04/30
Last modified on 2020/04/29

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Basic information
Public title impact on continuous acceleromyography use for intraoperative period
Acronym impact on continuous acceleromyography use for intraoperative period
Scientific Title impact on continuous acceleromyography use for intraoperative period
Scientific Title:Acronym impact on continuous acceleromyography use for intraoperative period
Region
Japan

Condition
Condition elective surgery patient
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Discovering a reliable use of acceleromyography and impact of continuous muscle relaxation during elective surgery.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intraoperative complications such as backing
Key secondary outcomes Rocuronium dose, TOF value at the end of surgery, amount of sugammadex required to antagonize rocuronium

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 Treatment
Type of intervention
Other
Interventions/Control_1 Using acceleromyography during surgery
Interventions/Control_2 Using rocuronium effect site concentration concentration during surgery
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
6 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients undergoing elective surgery under general anesthesia
Key exclusion criteria Neuromuscular diseases, Taking drugs that interact with muscle relaxants, BMI of 30 or more, Chronic renal failure, Cirrhosis.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Takayuki
Middle name
Last name Hasegawa
Organization Iwaki City Medical Center
Division name anesthesiology
Zip code 973-8555
Address 16 Kuzehara, Mihama Town, Iwaki City, Fukushima Prefecture
TEL 0246-26-3151
Email tahasegawa-fks@nmin.ac.jp

Public contact
Name of contact person
1st name Takayuki
Middle name
Last name Hasegawa
Organization Iwaki City Medical Center
Division name anesthesiology
Zip code 973-8555
Address 16 Kuzehara, Mihama Town, Iwaki City, Fukushima Prefecture
TEL 0246-26-3151
Homepage URL
Email tahasegawa-fks@nmin.ac.jp

Sponsor
Institute Iwaki City Medical Center
Institute
Department

Funding Source
Organization Iwaki City Medical Center
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Iwaki City Medical Center
Address 16 Kuzehara, Mihama Town, Iwaki City, Fukushima Prefecture
Tel 0246-26-3151
Email tahasegawa-fks@nmin.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
2020 Year 04 Month 30 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
2020 Year 04 Month 01 Day
Date of IRB
2020 Year 04 Month 13 Day
Anticipated trial start date
2020 Year 05 Month 01 Day
Last follow-up date
2021 Year 03 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
2020 Year 04 Month 29 Day
Last modified on
2020 Year 04 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045943

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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