UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012086 |
|---|---|
| Receipt number | 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 14:53:52 |
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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
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
saori.s@dent.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Dental Anesthesiology, Faculty of Dental Science, Kyushu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014126
