UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023717 |
|---|---|
| Receipt number | 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 17:52:55 |
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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
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
s_matsui@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Resuscitology, Shinshu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027306
