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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000012882
Receipt No. R000015052
Scientific Title Required propofol dose and time to emerge for anesthesia, affect by antiepileptics and disability
Date of disclosure of the study information 2014/01/18
Last modified on 2015/06/09

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Basic information
Public title Required propofol dose and time to emerge for anesthesia, affect by antiepileptics and disability
Acronym The propofol required dose and the emergence in intravenous sedation for patient with disability
Scientific Title Required propofol dose and time to emerge for anesthesia, affect by antiepileptics and disability
Scientific Title:Acronym The propofol required dose and the emergence in intravenous sedation for patient with disability
Region
Japan

Condition
Condition patients with neurological disorder who were treated under intravenous general anesthesia
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of the present study was to investigate the relationship between number of used antiepileptics and the propofol dose required for anesthesia and the time to emerge from anesthesia during dental treatment in patients with neurological disorders. We also investigated these parameters in relation to type of antiepileptics and relation to disability.


We examine a dose and the emergence of the anesthetic in the intravenous sedation according to the kind of the disability.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We measure predictive blood concentration, time for emergence and propofol dose.
Key secondary outcomes

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
15 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria The patient that an agreement was provided
Key exclusion criteria The cases that did not use TCI and BIS or did not consent of study were excluded.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kentaro Ouchi
Organization Kagoshima university hospital
Division name Anesthesia center
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima, 890-8544 JAPAN
TEL 099-275-5111
Email ken2006anes@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro OUCHI
Organization Kagoshima University
Division name Anesthesia center
Zip code
Address 8-35-1 Sakuragaoka, Kagoshima, 890-8544 JAPAN
TEL 099-275-5111
Homepage URL
Email ken2006anes@yahoo.co.jp

Sponsor
Institute Kagoshima university
Institute
Department

Funding Source
Organization Kagoshima university
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
2014 Year 01 Month 18 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 No longer recruiting
Date of protocol fixation
2007 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2014 Year 12 Month 31 Day
Date analysis concluded

Other
Other related information propofol dose required for anesthesia, time to emergence, and modelled propofol blood concentration at emergence were evaluated.

Management information
Registered date
2014 Year 01 Month 17 Day
Last modified on
2015 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015052

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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