UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023205 |
|---|---|
| Receipt number | 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 23:39:30 |
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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
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
mmurakami-tohoku@umin.ac.jp
Sponsor or person
Institute
Department of anesthesiology, Tohokukosai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026754
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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