UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014187 |
|---|---|
| Receipt number | R000016522 |
| Scientific Title | Effects of remifentanil concentrations on maximum mouth opening under general anesthesia |
| Date of disclosure of the study information | 2014/06/06 |
| Last modified on | 2017/05/26 15:27:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of remifentanil concentrations on maximum mouth opening under general anesthesia
Acronym
Maximum mouth opening and remifentanil concentrations
Scientific Title
Effects of remifentanil concentrations on maximum mouth opening under general anesthesia
Scientific Title:Acronym
Maximum mouth opening and remifentanil concentrations
Region
| Japan |
Condition
Condition
adult patients under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the hypothesis that remifentanil concentrations effect maximum mouth opening under general anesthesia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
maximum interincisal distance
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Remifentanil is administered to a patient intravenously to make its target effect site concentration 2 ng/ml.
Interventions/Control_2
Remifentanil is administered to a patient intravenously to make its target effect site concentration 4 ng/ml.
Interventions/Control_3
Remifentanil is administered to a patient intravenously to make its target effect site concentration 6 ng/ml.
Interventions/Control_4
Remifentanil is administered to a patient intravenously to make its target effect site concentration 8 ng/ml.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients who are eligible for i-gel insertion under general anesthesia.
Key exclusion criteria
Patients with temporomandibular joint disorder, communication difficulty, central incisor loss, mobile tooth.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Kawamoto |
Organization
Kumamoto Kinoh Hospital
Division name
Department of Anesthesiology
Zip code
Address
Yamamuro 6-8-1, Kita-ku, Kumamoto, Japan
TEL
0963458111
kawamotokazuhiko@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Kawamoto |
Organization
Kumamoto Kinoh Hospital
Division name
Department of Anesthesiology
Zip code
Address
Yamamuro 6-8-1, Kita-ku, Kumamoto, Japan
TEL
0963458111
Homepage URL
kawamotokazuhiko@hotmail.com
Sponsor or person
Institute
Kumamoto Kinoh Hospital
Institute
Department
Personal name
Funding Source
Organization
Kumamoto Kinoh Hospital
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
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 | 06 | 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
| 2013 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 06 | Day |
Last modified on
| 2017 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016522
