UMIN-CTR Clinical Trial

Basic information
Public title	The study to reduce the complications associated with BIS electrodes
Acronym	The study to reduce the complications associated with BIS electrodes
Scientific Title	The study to reduce the complications associated with BIS electrodes
Scientific Title:Acronym	The study to reduce the complications associated with BIS electrodes
Region	Japan

Condition
Condition	Patients, who are scheduled for elective surgery under general anesthesia with BIS monitoring.
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective of this study is to reduce the incidence of skin lesion associated with BIS electrodes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence of skin lesion associated with BIS electrodes
Key secondary outcomes	Patient's pain when BIS electrodes are applied

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Maneuver
Interventions/Control_1	BIS electrodes are applied to patients and pressed at the mean of anesthesiologists' subjective pressure per area of a single electrode for 5 seconds.
Interventions/Control_2	BIS electrodes are applied to patients and pressed at the minimum necessary pressure per area of a single electrode for 5 seconds.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Adult patients with American Society of Anesthesiologists physical status I or II will be scheduled for elective surgery under general anesthesia with the BIS monitoring.
Key exclusion criteria	Patients who are scheduled for surgery in prone position or with cardiopulmonary bypass are excluded. Patients with dermatosis, allergy or mental disorder are excluded. Patients who received chemotherapy, radiotherapy, corticosteroid, nonsteroidal anti-inflammatory drugs, opioids or psychotropic agents are excluded.
Target sample size	40

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Susumu Ide
Organization	Shinshu University School of Medicine
Division name	Department of Anesthesiology and Resuscitology
Zip code
Address	3-1-1 Asahi, Matsumoto-shi, Nagano 390-8621, Japan
TEL	0263-37-2670
Email	ide@shinshu-u.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Shuhei Matsui
Organization	Shinshu University School of Medicine
Division name	Department of Anesthesiology and Resuscitology
Zip code
Address	3-1-1 Asahi, Matsumoto-shi, Nagano 390-8621, Japan
TEL	0263-37-2670
Homepage URL
Email	s_matsui@shinshu-u.ac.jp

Sponsor
Institute	Department of Anesthesiology and Resuscitology, Shinshu University School of Medicine
Institute
Department

Funding Source
Organization	Department of Anesthesiology and Resuscitology, Shinshu University School of Medicine
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
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	信州大学医学部附属病院（長野県）、長野赤十字病院（長野県）

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 23 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	2016 Year 08 Month 23 Day
Date of IRB	2016 Year 06 Month 07 Day
Anticipated trial start date	2016 Year 08 Month 24 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 08 Month 22 Day
Last modified on	2019 Year 03 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027306