UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014179
Receipt number R000016513
Scientific Title Required propofol dose and time to emerge for anesthesia; affect by type of neurological disorder
Date of disclosure of the study information 2014/06/05
Last modified on 2015/01/14 12:26:33

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Basic information

Public title

Required propofol dose and time to emerge for anesthesia; affect by type of neurological disorder

Acronym

Required propofol dose and time to emerge for anesthesia

Scientific Title

Required propofol dose and time to emerge for anesthesia; affect by type of neurological disorder

Scientific Title:Acronym

Required propofol dose and time to emerge for anesthesia

Region

Japan


Condition

Condition

dental 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

We investigated the dose of propofol administered, the time to emerge from intravenous general anesthesia, and the modelled propofol blood concentration at emergence.

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

13 years-old <=

Age-upper limit

65 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

200


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

Department of Dental Anesthesiology, Field of Oral and Maxillofacial Rehabilitation,

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 or person

Institute

Department of Dental Anesthesiology, Field of Oral and Maxillofacial Rehabilitation, Kagoshima University Graduate School of Medical and Dental Sciences

Institute

Department

Personal name



Funding Source

Organization

Kagoshima University Graduate School of Medical and Dental Sciences

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


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 06 Month 05 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 04 Month 01 Day

Date of IRB


Anticipated trial start date

2007 Year 04 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

2014 Year 06 Month 05 Day

Last modified on

2015 Year 01 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016513


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name