UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017197 |
|---|---|
| Receipt number | R000019955 |
| Scientific Title | A new management method for propofol intravenous sedation using a target-controlled infusion (TCI) pump -The investigation of the optimal initial target blood concentration value in resetting strategy for the target blood concentration at optimal sedation level- |
| Date of disclosure of the study information | 2015/04/20 |
| Last modified on | 2024/03/08 11:16:19 |
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Basic information
Public title
A new management method for propofol intravenous sedation using a target-controlled infusion (TCI) pump
-The investigation of the optimal initial target blood concentration value in resetting strategy for the target blood concentration at optimal sedation level-
Acronym
The investigation of the optimal initial target blood concentration of propofol in resetting strategy for the target blood concentration at optimal sedation level using TCI pump
Scientific Title
A new management method for propofol intravenous sedation using a target-controlled infusion (TCI) pump
-The investigation of the optimal initial target blood concentration value in resetting strategy for the target blood concentration at optimal sedation level-
Scientific Title:Acronym
The investigation of the optimal initial target blood concentration of propofol in resetting strategy for the target blood concentration at optimal sedation level using TCI pump
Region
| Japan |
Condition
Condition
Mainly impacted teeth
Classification by specialty
| Anesthesiology | Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to find optimal initial target blood concentration value of propofol in resetting strategy for the target blood concentration at optimal sedation level-
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Maximum difference between the brain concentration at optimal sedation during induction and the target blood concentration at each point during surgery
2)The duration till optimal sedation was achieved
Key secondary outcomes
1)SPO2, blood pressure
2)Brain concentration at optimal sedation during induction
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
TCI is started after the initial target blood concentration of propofol have been set at 2.2mcg/ml.
Interventions/Control_2
TCI is started after the initial target blood concentration of propofol have been set at 2.6mcg/ml.
Interventions/Control_3
TCI is started after the initial target blood concentration of propofol have been set at 3.0mcg/ml.
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
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Forty-five patients who were scheduled to undergo oral surgery (mainly extraction of impacted tooth) under local anesthesia with intravenous sedation of propofol using the present method
Key exclusion criteria
habitual user of tranquilizer
patient with liver or renal dysfunction
obesity patient who's body mass index was more than 30%
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Toshiaki |
| Middle name | |
| Last name | Fujisawa |
Organization
Hokkaido University Hospital
Division name
Department of Dental Anesthesiology
Zip code
060-8648
Address
Kita-14, Nishi-5,Kita-ku, Sapporo 060-8648 Japan
TEL
011-706-4345
fujitosi@den.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Toshiaki |
| Middle name | |
| Last name | Fujisawa |
Organization
Hokkaido University Hospital
Division name
Department of Dental Anesthesiology
Zip code
060-8648
Address
Kita-14, Nishi-5,Kita-ku, Sapporo 060-8648 Japan
TEL
011-706-4345
Homepage URL
fujitosi@den.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Grant-in Aid for Scientific Rseearch (C) ,No. 30190028
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita-14, Nishi-5,Kita-ku, Sapporo 060-8648 Japan
Tel
011-706-7636
crjimu@huhp.hokudai.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
| 2015 | Year | 04 | Month | 20 | 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
The higher initial target blood concentration was set from 2.2mcg.ml, the shorter induction time was. However, Maximum difference between the brain concentration at each point during surgery was larger. That is, the most advantage of this method became impaired. Therefore, optimal initial blood concentration seemed to be 2.2mcg.ml in this method.
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
| 2010 | Year | 04 | Month | 07 | Day |
Date of IRB
| 2010 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2010 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 20 | Day |
Last modified on
| 2024 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019955
