UMIN-CTR Clinical Trial

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
Email	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
Email	mao511@hirosaki-u.ac.jp

Sponsor
Institute	Hirosaki University Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053778