UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027434 |
|---|---|
| Receipt number | R000031256 |
| Scientific Title | Predictive performance of target controlled infusion system in head down position |
| Date of disclosure of the study information | 2017/05/22 |
| Last modified on | 2019/03/25 10:12:40 |
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Basic information
Public title
Predictive performance of target controlled infusion system in head down position
Acronym
Propofol pharmacokinetics in head down position
Scientific Title
Predictive performance of target controlled infusion system in head down position
Scientific Title:Acronym
Propofol pharmacokinetics in head down position
Region
| Japan |
Condition
Condition
Diseases which require head down position with pneumoperitoneum during surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the predictive performance of target controlled infusion system in head down position
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Bias (median prediction error) and accuracy (median absolute prediction error) of predicted propofol concentrations compared to measured blood propofol concentrations.
Blood samples will be collected during general anesthesia for surgery.
Statistical analysis will be performed after the collection of a certain number of samples.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Propofol administration using target controlled infusion system targeting 3 mcg/ml during anesthesia for surgery
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
| 50 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male
Key inclusion criteria
Male patients who are scheduled to undergo elective surgery in head down position and provided written informed consent whose physical status are American Society of Anesthesiologists classification 1 or 2.
Key exclusion criteria
Exclusion criteria includes known allergy to propofol; psychoneurotic disorders; psychiatric pharmacotherapy; chronic use of NSAIDs or opioids; cirrhosis; anemia (hemoglobin <8 g/dL); and those who were considered inadequate.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Murakawa |
Organization
Fukushima Medical University
Division name
Anesthesiology
Zip code
9601295
Address
1 Hikarigaoka Fukushima City, Fukushima
TEL
0245471342
masui@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Shinju |
| Middle name | |
| Last name | Obara |
Organization
Fukushima Medical University
Division name
Surgical Operation Department
Zip code
9601295
Address
1 Hikarigaoka Fukushima City, Fukushima
TEL
0245471342
Homepage URL
masui@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
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
Fukushima Medical University Research Ethics Committee
Address
1 Hikarigaoka, Fukushima City, Fukushima, JAPAN
Tel
0245471825
rs@fmu.ac.jp
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
| 2017 | Year | 05 | Month | 22 | 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
15
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
| 2017 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 22 | Day |
Last modified on
| 2019 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031256
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
