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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048049
Receipt No. R000054729
Scientific Title Examination of effects of forearm position to supramaximal stimulation of electromyography - an observational study -
Date of disclosure of the study information 2022/08/01
Last modified on 2022/06/14

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Basic information
Public title Examination of effects of forearm position to supramaximal stimulation of electromyography - an observational study -
Acronym Examination of effects of forearm position to supramaximal stimulation of electromyography - an observational study -
Scientific Title Examination of effects of forearm position to supramaximal stimulation of electromyography - an observational study -
Scientific Title:Acronym Examination of effects of forearm position to supramaximal stimulation of electromyography - an observational study -
Region
Japan

Condition
Condition general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the magnitude of changes in the supramaximal stimulation of the electromyogram depending on the limb position of the forearm.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Difference in calibration value of electromyograph when the forearm is positioned in pronation and supination.
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
70 years-old >=
Gender Female
Key inclusion criteria 1.Patients undergoing gynecological laparoscopic surgery under general anesthesia at Ohama Dai-ichi Hospital from the date of approval to conduct the study to December 2022.
2.20 to 70 years old
3.American Society of Anesthesiologists Physical Status Class 1-3.
Key exclusion criteria 1.Patients planning to use muscle relaxants other than rocuronium bromide.
2.Pregnant women, patients with neuropathy/neuromuscular disease, patients with pacemakers
3.Patients allergic to rocuronium bromide and sugammadex sodium
4.Patients with skin abnormalities at the site of application of the monitor
5.Patients with limited range of motion of the upper extremity to be measured
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Misuzu
Middle name
Last name Hayashi
Organization Ohama Dai-ichi Hospital
Division name Department of anesthesiology
Zip code 900-0005
Address Ameku 1000, Naha-City, Okinawa prefecture, Japan
TEL 098-866-5171
Email mi_hayashi@ns.omotokai.jp

Public contact
Name of contact person
1st name Misuzu
Middle name
Last name Hayashi
Organization Ohama Dai-ichi Hospital
Division name Department of anesthesiology
Zip code 900-0005
Address Ameku 1000, Naha-City, Okinawa prefecture, Japan
TEL 098-866-5171
Homepage URL
Email mi_hayashi@ns.omotokai.jp

Sponsor
Institute Ohama Dai-ichi Hospital
Institute
Department

Funding Source
Organization None
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 the Ethics Committee of the University of the Ryukyus for Medical and Health Research Involving Human Subjects
Address 207, Uehara, Nishihara-cho, Nakagami-gun, Okinawa prefecture, Japan
Tel 098-895-1543
Email krinken@acs.u-ryukyu.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 08 Month 01 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
2022 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2022 Year 08 Month 01 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a study to observe changes in the value of maximal stimulation when the patient's forearm is rotated in and out during general anesthesia.

Management information
Registered date
2022 Year 06 Month 14 Day
Last modified on
2022 Year 06 Month 14 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054729

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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