UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017007 |
|---|---|
| Receipt number | R000019726 |
| Scientific Title | Clinical observational study on objective evaluation method of depth of anesthesia using infrared pupillometer. |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2015/04/01 12:56:58 |
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Basic information
Public title
Clinical observational study on objective evaluation method of depth of anesthesia using infrared pupillometer.
Acronym
Clinical observational study on objective evaluation method of depth of anesthesia using infrared pupillometer.
Scientific Title
Clinical observational study on objective evaluation method of depth of anesthesia using infrared pupillometer.
Scientific Title:Acronym
Clinical observational study on objective evaluation method of depth of anesthesia using infrared pupillometer.
Region
| Japan |
Condition
Condition
thyroid tumor, breast tumor, stroke, aortic lesion
Classification by specialty
| Surgery in general | Vascular surgery | Breast surgery |
| Anesthesiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We investigated the effects of various anesthetics on pupillary activity using an infrared pupillometer, and whether it could be objective indicator of wakefulness from anesthesia and anesthetic depth.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effects of opioid, intravenous anesthetic, muscle relaxants and volatile anesthetics on pupillary activity after light reflex.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients scheduled for breast, thyroid, thoracic aneurysm, cranial hematoma removal surgery were enrolled (from 1st July, 2014 to 31st December, 2015)
Key exclusion criteria
1. The patients who did not wish to be subject
2. The patients whose ASA physical status classification was 3 or more.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Shirozu |
Organization
Kyushu university hospital
Division name
Operating room
Zip code
Address
3-1-1 maedashi higashi-ku, Fukuoka Japan
TEL
+81-92-642-5714
shiron@kuaccm.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Shirozu |
Organization
Department of anesthesia
Division name
Operating room
Zip code
Address
3-1-1 maedashi higashi-ku, Fukuoka Japan
TEL
+81-92-642-5714
Homepage URL
shiron@kuaccm.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kazuhiro Shirozu
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2015 | Year | 04 | Month | 01 | 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
| 2014 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Pupillary reactivity was measured using a quantitative pupillometer at baseline before the induction of anesthesia, 5 min after administration of fentanyl, at the time of administration of a muscle relaxant, after tracheal intubation, 1 h after the start of surgery, and just before return to a ward.
We recorded maximum resting pupil size, minimum pupil size after stimulation, latency duration, constriction velocity, dilation velocity and neurological pupil index (NPi) in both eyes. The latter was calculated from the parameters described above according to a proprietary algorithm.
Management information
Registered date
| 2015 | Year | 04 | Month | 01 | Day |
Last modified on
| 2015 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019726
| Research Plan | |
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| 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 |
