UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017197
Receipt No. 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 2015/04/20

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Toshiaki Fujisawa
Organization Hokkaido University Hospital
Division name Department of Dental Anesthesiology
Zip code
Address Kita-14, Nishi-5,Kita-ku, Sapporo 060-8648 Japan
TEL 011-706-4345
Email fujitosi@den.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiaki Fujisawa
Organization Hokkaido University Hospital
Division name Department of Dental Anesthesiology
Zip code
Address Kita-14, Nishi-5,Kita-ku, Sapporo 060-8648 Japan
TEL 011-706-4345
Homepage URL
Email fujitosi@den.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization Grant-in Aid for Scientific Rseearch (C) ,No. 30190028
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
Anticipated trial start date
2010 Year 04 Month 22 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
2015 Year 04 Month 20 Day
Last modified on
2015 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019955

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.