UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015801 |
|---|---|
| Receipt number | R000017873 |
| Scientific Title | Blood concentration of propofol in pregnant women during target controlled infusion (TCI) |
| Date of disclosure of the study information | 2015/03/01 |
| Last modified on | 2015/08/30 10:28:58 |
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Basic information
Public title
Blood concentration of propofol in pregnant women during target controlled infusion (TCI)
Acronym
Blood concentration of propofol in pregnant woman during TCI
Scientific Title
Blood concentration of propofol in pregnant women during target controlled infusion (TCI)
Scientific Title:Acronym
Blood concentration of propofol in pregnant woman during TCI
Region
| Japan |
Condition
Condition
pregnancy
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To measure blood concentration of propofol during TCI in pregnant woman and conpared to expected blood concentrations.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The difference between the blood levels of the measured and predicted blood concentration of propofol in a pregnant woman
Key secondary outcomes
A propofol infusion dose required in order to maintain proper stillness
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
A propofol maintenance given dose required in order to maintain proper stillness
Key exclusion criteria
Minority
Those who were not able to get consent to an inspection
A 30 or more-BMI person
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Misako Takamatsu |
Organization
Niigata University Medical & Dental Hospital
Division name
Central operation part Department of anesthesia
Zip code
Address
951-8510
TEL
0252272328
misakotaka@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Misako Takamatsua |
Organization
Central operation part
Division name
Department of anesthesia
Zip code
Address
754, Ichibancho, Asahimachidori, Chuo-ku, Niigata-shi, Niigata
TEL
025-227-2328
Homepage URL
misakotaka@gmail.com
Sponsor or person
Institute
Niigata University Medical & Dental Hospital Department of Anesthesiology
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
| 2015 | Year | 03 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 09 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 31 | Day |
Other
Other related information
The Comparison of propofol concentration in the sampled blood and prediction blood concentration.
Management information
Registered date
| 2014 | Year | 12 | Month | 01 | Day |
Last modified on
| 2015 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017873
