UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023717
Receipt No. R000027306
Scientific Title The study to reduce the complications associated with BIS electrodes
Date of disclosure of the study information 2016/08/23
Last modified on 2019/03/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.