UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008733 |
|---|---|
| Receipt number | R000010100 |
| Scientific Title | Significant decreases in blood propofol concentrations during adrenalectomy for phaeochromocytoma |
| Date of disclosure of the study information | 2012/08/20 |
| Last modified on | 2018/11/14 18:24:59 |
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Basic information
Public title
Significant decreases in blood propofol concentrations during adrenalectomy for phaeochromocytoma
Acronym
Significant decreases in blood propofol concentrations during adrenalectomy for phaeochromocytoma
Scientific Title
Significant decreases in blood propofol concentrations during adrenalectomy for phaeochromocytoma
Scientific Title:Acronym
Significant decreases in blood propofol concentrations during adrenalectomy for phaeochromocytoma
Region
| Japan |
Condition
Condition
pheochromocytoma
Classification by specialty
| Endocrine surgery | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationship between hemodynamic changes and propofol blood concentration during propofol anesthesia for pheochromocytoma surgery
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of propofol blood concentration
Key secondary outcomes
Change of hepatic blood flow
Change of bispectral index
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patient underwent unilateral adrenalectomy for pheochromocytoma
Key exclusion criteria
Central nervous system diseases prior to surgery
Allergy of propofol,soybeans and albumen
Disease which reduces reliability of the Flowtrack
Reduced cardiac function
Not obtained the informed consent
Administration of albumin by the bleeding during surgery
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Baba |
Organization
Niigata University
Division name
Department of Anesthesiology
Zip code
Address
1-757 Asahimachi, Chuo-ku, Niigata
TEL
025-227-2328
baba@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsunori Watanabe |
Organization
Niigata University
Division name
Department of Anesthesiology
Zip code
Address
1-757 Asahimachi, Chuo-ku, Niigata
TEL
025-227-2328
Homepage URL
t-wata@med.niigata-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology
Niigata University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
Niigata Medical Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Clinical Pharmacology, Gunma University Graduate School of Medicine
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
| 2012 | Year | 08 | Month | 20 | 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
| 2011 | Year | 10 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To examine the relationship between hemodynamic changes and bispectral index during propofol anesthesia for pheochromocytoma surgery
Management information
Registered date
| 2012 | Year | 08 | Month | 20 | Day |
Last modified on
| 2018 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010100
