UMIN-CTR Clinical Trial

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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