UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025007 |
|---|---|
| Receipt number | R000028772 |
| Scientific Title | An observational study examining relationship of evoked response between m. abductor pollicis and m. orbicularis oculi during deep neuromuscular blockade in surgical patients. |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2019/12/02 08:15:31 |
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Basic information
Public title
An observational study examining relationship of evoked response between m. abductor pollicis and m. orbicularis oculi during deep neuromuscular blockade in surgical patients.
Acronym
Relationship of evoked response between m. abductor pollicis and m. orbicularis oculi during deep neuromuscular blockade
Scientific Title
An observational study examining relationship of evoked response between m. abductor pollicis and m. orbicularis oculi during deep neuromuscular blockade in surgical patients.
Scientific Title:Acronym
Relationship of evoked response between m. abductor pollicis and m. orbicularis oculi during deep neuromuscular blockade
Region
| Japan |
Condition
Condition
Patients undergoing surgery for intraabdominal malignancies
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Obstetrics and Gynecology |
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Validation of accuracy of neuromuscular monitoring at m. orbiuclaris oculi during deep neuromuscular blockade
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation of the evoked response between m. abductor pollicis and m. orbicularis oculi during anesthesia
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing curative surgery for intraabdominal malignancies under general anesthesia
Key exclusion criteria
Patients who have known allergy to neuromuscular blocking agents.
Patients who have known neuromuscular diseases.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshifumi |
| Middle name | |
| Last name | iKotake |
Organization
Toho University Ohashi Medical Center
Division name
Department of Anesthesiology
Zip code
1538515
Address
2-17-6 Ohashi, Meguro, Tokyo, Japan
TEL
03-3468-1251
ykotake@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Kotake |
Organization
Toho University Ohashi Medical Center
Division name
Department of Anesthesiology
Zip code
1538515
Address
2-17-6 Ohashi, Meguro, Tokyo, Japan
TEL
03-3468-1251
Homepage URL
ykotake@med.toho-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Toho University Ohashi Medical Center
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Toho University Ohashi Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Comittee of Toho University Ohashi Medical Center
Address
2-17-16, Ohashi, Meguro, Tokyo
Tel
0334681251
secretary@oha.toho-u.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
| 2016 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
60
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Preparing presentation at scientific meeting
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
| 2016 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 31 | Day |
Other
Other related information
The observational study aims to determine the relationship between the twitch responses at two different monitoring sites ie, m. abductor pollicis and m. orbicularlis oculi in patients undergoing general surgery and administration of neuromuscular blocking agents.
Management information
Registered date
| 2016 | Year | 11 | Month | 27 | Day |
Last modified on
| 2019 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028772
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
