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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | general anesthesia | |
Classification by specialty |
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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 | |
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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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 |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
mi_hayashi@ns.omotokai.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 | |
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Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
Date of protocol fixation |
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Last follow-up date |
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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 |
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Last modified on |
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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 |