UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034692 |
|---|---|
| Receipt number | R000039543 |
| Scientific Title | Monitoring the level of muscular relaxation by real-time ultrasound elastography. |
| Date of disclosure of the study information | 2018/10/30 |
| Last modified on | 2025/09/22 12:28:39 |
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Basic information
Public title
Monitoring the level of muscular relaxation by real-time ultrasound elastography.
Acronym
Monitoring the level of muscular relaxation by real-time ultrasound elastography.
Scientific Title
Monitoring the level of muscular relaxation by real-time ultrasound elastography.
Scientific Title:Acronym
Monitoring the level of muscular relaxation by real-time ultrasound elastography.
Region
| Japan |
Condition
Condition
Patients who are scheduled for abdomen and limb operation
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the muscular contraction and relaxation using ultrasonic elastography. The main purpose of this study is to measure the appropriate modulus of muscular elasticity for the operation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
It can be evaluated by the modulus of muscular elasticity which can be obtained by images of the elastography mode of ultrasonography.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Evaluate muscular relaxation qualitatively and quantitatively using elastography in 40 patients who have abdomen surgery. Inspection is done for at least four times for one patient, before anesthesia, before muscular relaxant is infused after anesthesia induction, after muscular relaxant is induced, and after peripheral nerve block.
Interventions/Control_2
As same as control 1 in patients who have arm surgery.
Interventions/Control_3
As same as control 1 in patients who have leg surgery.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have abdomen and limb operation.
Key exclusion criteria
Patients who have or suspected to have allergies against muscular relaxants, patients who have neuromuscular disease, drug abusers, and who is under 20 years old.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Yamauchi |
Organization
Tohoku university school of medicine
Division name
department of anesthesiology
Zip code
980-8575
Address
2-1 Seiryouchou, Aoba-ku, Sendai-shi, Miyagi prefecture
TEL
022-717-7321
yamauchi@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hidehisa |
| Middle name | |
| Last name | Saito |
Organization
Tohoku university school of medicine
Division name
Department of anesthesiology
Zip code
980-8575
Address
2-1 Seiryouchou, Aoba-ku, Sendai-shi, Miyagi prefecture
TEL
022-717-7321
Homepage URL
hidehisa.saito.e2@tohoku.ac.jp
Sponsor or person
Institute
Department of anesthesiology, Tohoku university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Department of anesthesiology, Tohoku university school of medicine
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
Department of anesthesiology, Tohoku university school of medicine
Address
2-1 Seiryouchou, Aoba-ku, Sendai-shi, Miyagi prefecture
Tel
022-717-7321
hidehisa.saito.e2@tohoku.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
| 2018 | Year | 10 | 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
75
Results
The SWVs in the baseline, opioid-induced rigidity, and muscle relaxation conditions after the adjustment were 2.08, 2.41, and 1.79m/s, respectively (p < 0.001 at all comparisons).
The present study suggested that the SWV as reference was 1.79 m/s and that the SWVs at rest and opioid-induced rigidity were 10 to 30% increase from the reference, respectively. The SWV adjusted for the subcutaneous fat thickness may be scale points for the assessment of muscle tone.
Results date posted
| 2025 | Year | 09 | Month | 22 | Day |
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
| 2018 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2027 | 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
| 2018 | Year | 10 | Month | 30 | Day |
Last modified on
| 2025 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039543
