UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038214 |
|---|---|
| Receipt number | R000043328 |
| Scientific Title | Effect of anesthetic agents on nociceptive evoked potentials |
| Date of disclosure of the study information | 2019/10/20 |
| Last modified on | 2022/09/08 11:59:37 |
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Basic information
Public title
Effect of anesthetic agents on nociceptive evoked potentials
Acronym
Effect of anesthetic agents on nociceptive evoked potentials
Scientific Title
Effect of anesthetic agents on nociceptive evoked potentials
Scientific Title:Acronym
Effect of anesthetic agents on nociceptive evoked potentials
Region
| Japan |
Condition
Condition
patients who get general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the effect of anesthetic agents on nociceptive evoked potentials using intra-epidermal stimulation
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amplitude of nociceptive evoked potentials
Key secondary outcomes
Latency of nociceptive evoked potentials
Numerical Rating Scale of pain
Bispectral Index
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
5
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
intravenous administration of remifentanil
effect-site concentration: 1.0-3.0 nanogram/ml, 5 minutes
Interventions/Control_2
intravenous administration of propofol
effect-site concentration: 0.5-1.0 microgram/ml, 5 minutes
Interventions/Control_3
inhalation of sevoflurane
0.2-0.5 age-related minimum alveolar concentration, 5 minutes
Interventions/Control_4
intravenous administration of propofol
effect-site concentration: 0.5-1.0 microgram/ml, 5 minutes, 2 times
Interventions/Control_5
inhalation of sevoflurane
0.2-0.5 age-related minimum alveolar concentration, 5 minutes, 2 times
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 over 20 years old who get surgery under general anesthesia in our hospital
Key exclusion criteria
1) ASA-PS over 3
2) surgery for malignancy or electrode site
3) diabetes mellitus, dementia or epilepsy
4) inpanted pacemaker, implantable cardioverter-defibrillator or deep brain stimulator
5) skin disorder or paresthesia on electrode site
6) patients without consent
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Ishida |
Organization
Shinshu University School of Medicine
Division name
The Department of Anesthesiology and Resuscitology
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2670
tisd@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Ishida |
Organization
Shinshu University School of Medicine
Division name
The Department of Anesthesiology and Resuscitology
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2670
Homepage URL
tisd@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shinshu University School of Medicine
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
Shinshu University School of Medicine Research Ethics Committee
Address
3-1-1 Asahi, Matsumoto, Nagano
Tel
0263-37-2572
mdrinri@shinshu-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
| 2019 | Year | 10 | Month | 20 | 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
55
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
| 2019 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2019 | Year | 10 | Month | 06 | Day |
Last modified on
| 2022 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043328
