UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014879 |
|---|---|
| Receipt number | R000017304 |
| Scientific Title | Evaluation of analgesic effect of analgesic agents used perioperatively. |
| Date of disclosure of the study information | 2014/08/25 |
| Last modified on | 2023/02/23 14:06:32 |
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Basic information
Public title
Evaluation of analgesic effect of analgesic agents used perioperatively.
Acronym
Evaluation of analgesic effect under anesthesia
Scientific Title
Evaluation of analgesic effect of analgesic agents used perioperatively.
Scientific Title:Acronym
Evaluation of analgesic effect under anesthesia
Region
| Japan |
Condition
Condition
Patients included are greater than 20 years of age, scheduled for surgery.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It has been challenging to evaluate analgesic effects during general anesthesia because patients are unconscious. The purpose of the present study is to evaluate of analgesic effect of analgesic agents used perioperatively.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain visual analogue scale
Sensory/pain-evoked potentials
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Stimulation electrodes that activate sensory fibers are placed in the hand or foot of the patients and recording electrodes for evoked potentials are placed on the Cz, C3, and C4. Evoked potentials are recorded during stepwise increase of the analgesics before and afteradministration of a sedative. remifentanil group.
Interventions/Control_2
Stimulation electrodes that activate sensory fibers are placed in the hand or foot of the patients and recording electrodes for evoked potentials are placed on the Cz, C3, and C4. Evoked potentials are recorded during stepwise increase of the analgesics before and afteradministration of a sedative. fentanyl group.
Interventions/Control_3
Stimulation electrodes that activate sensory fibers are placed in the hand or foot of the patients and recording electrodes for evoked potentials are placed on the Cz, C3, and C4. Evoked potentials are recorded during stepwise increase of the analgesics before and after administration of a sedative. local anesthetic group.
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 included are greater than 20 years of age, scheduled for surgery.
Key exclusion criteria
Patients with a history of alcohol or drug abuse or severe neurologic disease are excluded from the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Tanaka |
Organization
Shinshu University School of medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
Address
3-1-1 Asahi, Matsumoto, Nagano 390-8621, Japan
TEL
0263-37-2670
s_tanaka@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Tanaka |
Organization
Shinshu University School of medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
Address
Department of Anesthesiology and Resuscitology
TEL
0263-37-2670
Homepage URL
s_tanaka@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Resuscitology, Shinshu University School of medicine
Institute
Department
Personal name
Funding Source
Organization
donation money for research
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
Address
Tel
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
| 2014 | Year | 08 | Month | 25 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 12 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 18 | Day |
Last modified on
| 2023 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017304
