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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017007
Receipt No. 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

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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
Email 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
Email shiron@kuaccm.med.kyushu-u.ac.jp

Sponsor
Institute Kazuhiro Shirozu
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019726

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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