UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047145 |
|---|---|
| Receipt number | R000053778 |
| Scientific Title | Feasibility of monitoring depth of analgesia by ultrasound of pupillary dilated reflex diameter in response to nociceptive stimulation |
| Date of disclosure of the study information | 2022/03/11 |
| Last modified on | 2022/03/11 00:32:01 |
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Basic information
Public title
Feasibility of monitoring depth of analgesia by ultrasound of pupillary dilated reflex diameter in response to nociceptive stimulation
Acronym
Feasibility of monitoring depth of analgesia by ultrasound of pupillary dilated reflex diameter in response to nociceptive stimulation
Scientific Title
Feasibility of monitoring depth of analgesia by ultrasound of pupillary dilated reflex diameter in response to nociceptive stimulation
Scientific Title:Acronym
Feasibility of monitoring depth of analgesia by ultrasound of pupillary dilated reflex diameter in response to nociceptive stimulation
Region
| Japan |
Condition
Condition
Adult healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The pupillary dilated reflex in response to painful stimuli has attracted attention as an indicator of the depth of analgesia. However, frequent eye-opening maneuvers are associated with the risk of corneal damage and infection. This study aims to investigate the reproducibility of pupil measurement by ultrasonography as an alternative to electronic pupillometry, we will compare and investigate the change in pupil diameter due to pain stimulation using each measurement device.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Pupil dilation reflex change in response to noxious stimulation measured by infrared video pupillometry and ultrasonography.
Key secondary outcomes
NRS(Numerical Rating Scale) after noxious stimulation.
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults.
Key exclusion criteria
Any ocular disease , neurological diseases , history of any type of ocular surgery or laser treatment and taking topical or systemic medications potentially affecting pupillary function.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Mao |
| Middle name | |
| Last name | Konno |
Organization
Hirosaki University Hospital
Division name
Anesthesiology
Zip code
036-8563
Address
Aomori Prefecture, Hirosaki City, 53 Honcho
TEL
0172-33-5111
mao511@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Mao |
| Middle name | |
| Last name | Konno |
Organization
Hirosaki University Hospital
Division name
Anesthesiology
Zip code
036-8563
Address
Aomori Prefecture, Hirosaki City, 53 Honcho
TEL
0172-33-5111
Homepage URL
mao511@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University Hospital
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
Hirosaki University Hospital
Address
Aomori Prefecture, Hirosaki City, 53 Honcho
Tel
0172-33-5111
mao511@hirosaki-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
| 2022 | Year | 03 | Month | 11 | 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
| 2019 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study was a prospective observational study and participants were recruited by an open call poster between January and June 2020.
Management information
Registered date
| 2022 | Year | 03 | Month | 11 | Day |
Last modified on
| 2022 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053778
