UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011231 |
|---|---|
| Receipt number | R000013160 |
| Scientific Title | The impact of induction anesthesia on the accuracy of non-invasive continuos hemoglobin measurement |
| Date of disclosure of the study information | 2013/07/19 |
| Last modified on | 2018/11/06 14:45:26 |
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Basic information
Public title
The impact of induction anesthesia on the accuracy of non-invasive continuos hemoglobin measurement
Acronym
Induction of anesthesia and the accuracy of non-invasive continuous hemoglobinmeasurement
Scientific Title
The impact of induction anesthesia on the accuracy of non-invasive continuos hemoglobin measurement
Scientific Title:Acronym
Induction of anesthesia and the accuracy of non-invasive continuous hemoglobinmeasurement
Region
| Japan |
Condition
Condition
Patients who need an operation under fgeneral anesthesia
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Vascular surgery | Chest surgery | Endocrine surgery |
| Breast surgery | Obstetrics and Gynecology | Ophthalmology |
| Dermatology | Oto-rhino-laryngology | Orthopedics |
| Urology | Oral surgery | Neurosurgery |
| Cardiovascular surgery | Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Changes in perfusion index have a potential to affect the accuray of non-invasive hemoglobin measurement. Anesthesia can change in perfusion index. The purpose of this study is how induction of anesthesia affect on the accuracy of non-invasive hemoglobin measurement
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference between non-invasive continuous hemoglobin (SpHb) and hemoglobin before and after induction of anesthesia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Continuous infusion of phenylephrine (0.5mcg/kg/min) during induction of anesthesia
Interventions/Control_2
No drug infusion
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
1. Patients aged >= 20 years to =< 80 years at informed consent
2. Patients who need an operation under general anesthesia
3. ASA 1 or 2
Key exclusion criteria
1. Past history of hypertension
2. Past history of intra cerebral hemorrhage
3. Past history of cerebral aneurysm and thoracic or abdominal aortic aneurysm
4. Past history of hypersensitivity for Phenylephrine
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichi Saito |
Organization
Hirisaki University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
zaifu-cho 5, Hirosaki, Aomori, Japan
TEL
0172395113
fix-you@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichi Saito |
Organization
Hirisaki University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
5 zaifucho, Hirosaki
TEL
0172-33-5111
Homepage URL
fix-you@hotmail.co.jp
Sponsor or person
Institute
Department of Anesthesiology, Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Hirosaki University Graduate School of Medicine
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
| 2013 | Year | 07 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 07 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 20 | 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
| 2013 | Year | 07 | Month | 19 | Day |
Last modified on
| 2018 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013160
