UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000008711
Receipt No. R000009989
Scientific Title The influence of oral valproate on propofol metabolism
Date of disclosure of the study information 2012/08/18
Last modified on 2020/02/04 (Ver. 12)

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Basic information
Public title The influence of oral valproate on propofol metabolism
Acronym The influence of oral valproate on propofol metabolism
Scientific Title The influence of oral valproate on propofol metabolism
Scientific Title:Acronym The influence of oral valproate on propofol metabolism
Region
Japan

Condition
Condition Patients with oral valproate
Classification by specialty
Neurology Anesthesiology Dental medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the influence of oral valproate on propofol metabolism by general anesthesia with propofol
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The change of BIS index during anesthesia induction, the serum concentration of propofol after injection and the change of blood pressure and heart rate during anesthesia
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Participants of the present study are patients who have the plan of a general anesthesia in Okayama university hospital.
Key exclusion criteria Patients without consent of the study
Target sample size 48

Research contact person
Name of lead principal investigator
1st name Miyawaki
Middle name
Last name Takuya
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Dental Anesthsiology and Special Care Dentistry
Zip code 700-8525
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL 086-235-6721
Email miyawaki@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name Hitoshi
Middle name
Last name Higuchi
Organization Okayama University Hospital
Division name Dental Anesthesiology
Zip code 700-8525
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL 086-235-6721
Homepage URL
Email higuti@md.okayama-u.ac.jp

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Dental Anesthsiology and Special Care Dentistry
Institute
Department

Funding Source
Organization Okayama University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization The Ethics Committee of Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Address 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
Tel 086-235-6762
Email mae6605@adm.okayama-u.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
2012 Year 08 Month 18 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.nature.com/articles/s41598-020-58460-2
Number of participants that the trial has enrolled 33
Results 
There were no significant differences in the propofol level at 5, 10, 15, and 20 min or the free propofol level at 5 min after the intravenous administration of propofol. However, the minimum BIS was significantly lower and the time until the BIS exceeded 60 was significantly longer in the poly-VPA group. In the multivariate regression analysis, belonging to the poly-VPA group was found to be independently associated with the minimum BIS value and the time until the BIS exceeded 60.
Results date posted
2020 Year 02 Month 04 Day
Results Delayed
Delay expected
Results Delay Reason Data analysis and paper writing are in progress now.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events 
Nothing
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 02 Month 28 Day
Date of IRB
2012 Year 02 Month 28 Day
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective cohort study
We compare differences among three groups: the group of the patients with valproate acid, the one of patients with anti epileptic drugs with other than valproate acid and the one of patients without anti epileptic drugs.

Management information
Registered date
2012 Year 08 Month 17 Day
Last modified on
2020 Year 02 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009989