UMIN-CTR Clinical Trial

Basic information
Public title	Required propofol dose and time to emerge for anesthesia; affect by number of used antiepileptics and type of used antiepileptics
Acronym	Required propofol dose and time to emerge for anesthesia
Scientific Title	Required propofol dose and time to emerge for anesthesia; affect by number of used antiepileptics and type of used antiepileptics
Scientific Title:Acronym	Required propofol dose and time to emerge for anesthesia
Region	Japan

Condition
Condition	patients with neurological disorder who were treated under intravenous general anesthesia
Classification by specialty	Anesthesiology
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.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	anesthesia finish
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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	patients with neurological disorder who were treated under intravenous general anesthesia at the Dentistry outpatient section for patients with neurological disorder, Kagoshima University Medical Dental Hospital
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 Graduate School of Medical and Dental Sciences
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	Department of Dental Anesthesiology, Field of Oral and Maxillofacial Rehabilitation, Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department

Funding Source
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
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 06 Month 02 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
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	2015 Year 06 Month 02 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=R000020595

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Contact us.