UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030713 |
|---|---|
| Receipt number | R000035054 |
| Scientific Title | Examination of the sensory threshold in patients using perioperative opioid. |
| Date of disclosure of the study information | 2018/01/31 |
| Last modified on | 2020/07/09 17:20:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Examination of the sensory threshold in patients using perioperative opioid.
Acronym
Examination of the sensory threshold in patients using perioperative opioid.
Scientific Title
Examination of the sensory threshold in patients using perioperative opioid.
Scientific Title:Acronym
Examination of the sensory threshold in patients using perioperative opioid.
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the elevation of sensory threshold in patients using perioperative opioids.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The sensory and pain threshold.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Twice (before and after surgery)
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who weigh from 40 to 80 kilograms.
Key exclusion criteria
1.Dementia, consciousness disorder, and psychiatric disorder.
2.Aphasia, auditory disorder, and total blind.
3.Sensory disturbance.
4.Patients who can not equip an electrode because of the skin lesions.
5.Patients who use an implanted pacemaker, and a spinal cord stimulation.
6.Patients who use an implanted defibrillator.
7.Patients who use an opioid before surgery.
8.Patients who use a regional anesthesia.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Norihito |
| Middle name | |
| Last name | Hayashi |
Organization
Kitasato University School of Medicine
Division name
Department of Anesthesiology
Zip code
2520374
Address
1-15-1 Kitasato Minami-ku, Sagamihara, Kanagawa
TEL
0427788111
mininoriton@ybb.ne.jp
Public contact
Name of contact person
| 1st name | Norihito |
| Middle name | |
| Last name | Hayashi |
Organization
Kitasato University School of Medicine
Division name
Department of Anesthesiology
Zip code
2520374
Address
1-15-1 Kitasato Minami-ku, Sagamihara, Kanagawa
TEL
0427788111
Homepage URL
mininoriton@ybb.ne.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Kitasato University School of Medicine
Address
1-15-1 Kitasato Minami-ku, Sagamihara, Kanagawa
Tel
0427788111
rinri@med.kitasato-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
| 2018 | Year | 01 | Month | 31 | 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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 01 | 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 | 01 | Month | 06 | Day |
Last modified on
| 2020 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035054
