UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012864 |
|---|---|
| Receipt number | R000015031 |
| Scientific Title | The effect of ephedrine and etilefrine on perfusion index and pleth variability indicate |
| Date of disclosure of the study information | 2014/01/15 |
| Last modified on | 2016/07/15 14:41:02 |
* 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 effect of ephedrine and etilefrine on perfusion index and pleth variability indicate
Acronym
The effect of ephedrine and etilefrine on perfusion index and pleth variability indicate
Scientific Title
The effect of ephedrine and etilefrine on perfusion index and pleth variability indicate
Scientific Title:Acronym
The effect of ephedrine and etilefrine on perfusion index and pleth variability indicate
Region
| Japan |
Condition
Condition
surgical procedure under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate prospectively changes in perfusion index and pleth variability by injection of ephedrine or etilefrine.
Basic objectives2
Others
Basic objectives -Others
To investigate prospectively changes in other hemodynamic values by injection
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in perfusion index and pleth variability indicate values
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
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Immediately before administering the drug, baseline values are recorded, and the values are recorded again for 5 minutes after ephedrine 10mg injection.
Interventions/Control_2
Immediately before administering the drug, baseline values are recorded, and the values are recorded again for 5 minutes after etilefrine 2mg injection.
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
Patients with ASA physical status 1 or 2
Key exclusion criteria
1. Subjects who have an inappropriate clinical history for efficacy and safety
assessment in the study (such as drug poisoning, alcoholism, and the disease of heart, liver, kidney, lungs, eye, blood, etc)
and who is taking any drugs (including health supplements).
2. Any history for drug allergy.
3. Subjects who are inadequate for enrollment judged by the investigator.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Zen'ichiro Wajima |
Organization
Shioya hospital, International University of Health and Welfare
Division name
Department of Anesthesiology
Zip code
Address
77 Tomita Yaita-shi, Tochigi, Japan
TEL
0287-44-1155
zwajima@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Zen'ichiro Wajima |
Organization
Shioya hospital, International University of Health and Welfare
Division name
Department of Anesthesiology
Zip code
Address
77 Tomita Yaita-shi, Tochigi, Japan
TEL
0287-44-1155
Homepage URL
zwajima@iuhw.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Shioya Hospital, International University of Health and Welfare
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 15 | 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
| 2013 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 15 | Day |
Last modified on
| 2016 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015031
