UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048049 |
|---|---|
| Receipt number | 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 | 2022/12/14 17:04:13 |
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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
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
mi_hayashi@ns.omotokai.jp
Sponsor or person
Institute
Ohama Dai-ichi Hospital
Institute
Department
Personal name
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
| 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
40
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 01 | 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 | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054729
