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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012086
Receipt No. R000014126
Scientific Title Study of the preventive effect of the adverse event by asimple action at the introduction of general anesthesia.
Date of disclosure of the study information 2013/10/21
Last modified on 2014/11/12

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Basic information
Public title Study of the preventive effect of the adverse event by asimple action at the introduction of general anesthesia.
Acronym Study of the preventive effect of the adverse event by asimple action at the introduction of general anesthesia.
Scientific Title Study of the preventive effect of the adverse event by asimple action at the introduction of general anesthesia.
Scientific Title:Acronym Study of the preventive effect of the adverse event by asimple action at the introduction of general anesthesia.
Region
Japan

Condition
Condition Surgical patients
Classification by specialty
Anesthesiology Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate the relation between occurrence of fentanyl-induced cough and swallowing action .
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The presence or absence of cough reflex
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
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria ASA physical Status classification : 1~2
Patient's anesthesia was induced with intravenous fentanyl first.
Key exclusion criteria Patient is allergic to fentanyl.
Patient have a history of pulmonary problems (ex.asthma).
Inadequate patients determied by anesthesiologist
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Yokoyma
Organization Department of Dental Anesthesiology, Faculty of Dental Science, Kyushu University
Division name Department of Dental Anesthesiology
Zip code
Address 3-1-1 Maidashi Higashi-ku Fukuoka,812-8582 Japan
TEL 0926426480
Email yokoyama@dent.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Saori Sako
Organization Department of Dental Anesthesiology, Faculty of Dental Science, Kyushu University
Division name Department of Dental Anesthesiology
Zip code
Address 3-1-1 Maidashi Higashi-ku Fukuoka,812-8582 Japan
TEL 0926426480
Homepage URL
Email saori.s@dent.kyushu-u.ac.jp

Sponsor
Institute Department of Dental Anesthesiology, Faculty of Dental Science, Kyushu University
Institute
Department

Funding Source
Organization Department of Dental Anesthesiology, Faculty of Dental Science, Kyushu University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor St.Mary's Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 13-1201
Org. issuing International ID_1 St.Mary's Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 九州大学病院(福岡県)聖マリア病院(福岡県)

Other administrative information
Date of disclosure of the study information
2013 Year 10 Month 21 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 Completed
Date of protocol fixation
2012 Year 12 Month 14 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 28 Day
Last follow-up date
2014 Year 07 Month 31 Day
Date of closure to data entry
2014 Year 08 Month 31 Day
Date trial data considered complete
2014 Year 08 Month 31 Day
Date analysis concluded

Other
Other related information prospective study

Management information
Registered date
2013 Year 10 Month 21 Day
Last modified on
2014 Year 11 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014126

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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