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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023205
Receipt No. R000026754
Scientific Title Can remote ischemic conditioning prevent "blanchable erythema" during general anesthesia ?
Date of disclosure of the study information 2016/07/20
Last modified on 2018/11/28

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Basic information
Public title Can remote ischemic conditioning prevent "blanchable erythema" during general anesthesia ?
Acronym A placebo-controlled, randomized clinical trial assessing the prophylactic effect of remote ischemic conditioning on blanchable erythema
Scientific Title Can remote ischemic conditioning prevent "blanchable erythema" during general anesthesia ?
Scientific Title:Acronym A placebo-controlled, randomized clinical trial assessing the prophylactic effect of remote ischemic conditioning on blanchable erythema
Region
Japan

Condition
Condition Blanchable sacral erythema during surgery under general anesthesia
Classification by specialty
Dermatology Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the prophylactic effect of remote ischemic conditioning on blanchable sacral erythema during surgery under general anesthesia with a randomized clinical trial
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The frequency of blanchable erythema observed at the end of general anesthesia comparing two groups: placebo group and remote ischemic conditioning group
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 RIC group:Soon after induction of general anesthesia, remote ischemic conditioning (RIC) is conducted. RIC consists of occlusion cuffs placed proximally around arm that is rapidly inflated to 250 mmHg for 5 min and deflated for 5 min of reperfusion. This procedure was repeated three times. Every 2 hours after first RIC, three-times RIC procedure is added.
Interventions/Control_2 CON group: Soon after induction of general anesthesia, control procedure (CON) is conducted. CON consists of occlusion cuffs placed around arm model that is rapidly inflated to 250 mmHg for 5 min and deflated for 5 min. This procedure was repeated three times. Every 2 hours after first CON, three-times CON procedure is added.
CON procedure does not cause ischemia.
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 endoscopic sinus surgery
general anesthesia
ASA-PS I or II
Key exclusion criteria 1.Sensory disturbance
2.Iimpaired consciousness
3.Impared ADL
4.History of pressure ulcer
5.Vascular diseases
6.History of heart failure (NYHA classification > 2)
7.Edema
8.Impaired renal function (estimated GFR < 60)
9.Electrolyte imbalance
10.Hypoproteinemia or hypoalbuminemia
11.Urinary incontinence or fecal incontinence
12.Fever (axillary body temperature > 37 degreeC)
13.Undernutrition
14.Impaired ingestion
15. hemorrhagic diathesis or coagulation disorders
16.Anticoagulants or antiplatelet drugs
17.History of deep vein thrombosis
18.Abormal preoperative D-dimer
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mamoru Murakami
Organization Tohokukosai Hospital
Division name Department of anesthesiology
Zip code
Address Kokubuncho2-3-11, Aobaku, Sendai, Miyagi, Japan
TEL +08-22-227-2211
Email mmurakami-tohoku@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mamoru Murakami
Organization Tohokukosai Hospital
Division name Department of anesthesiology
Zip code
Address Kokubuncho2-3-11, Aobaku, Sendai, Miyagi, Japan
TEL +08-22-227-2211
Homepage URL
Email mmurakami-tohoku@umin.ac.jp

Sponsor
Institute Department of anesthesiology, Tohokukosai Hospital
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 東北公済病院(宮城県)

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 20 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 07 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 21 Day
Last follow-up date
Date of closure to data entry
2018 Year 07 Month 30 Day
Date trial data considered complete
2018 Year 11 Month 20 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 07 Month 17 Day
Last modified on
2018 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026754

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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