UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025898 |
|---|---|
| Receipt number | R000016578 |
| Scientific Title | Application of remifentanil to intravenous sedation in the patients compromised with severe gag reflex |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2017/01/30 10:36:29 |
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Basic information
Public title
Application of remifentanil to intravenous sedation in the patients compromised with severe gag reflex
Acronym
Application of remifentanil under intravenous sedation to the patients compromised with severe gag reflex
Scientific Title
Application of remifentanil to intravenous sedation in the patients compromised with severe gag reflex
Scientific Title:Acronym
Application of remifentanil under intravenous sedation to the patients compromised with severe gag reflex
Region
| Japan |
Condition
Condition
gag reflex in dental procedure
Classification by specialty
| Anesthesiology | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to identify optimal remifentanil dose to avoid a severe gag reflex dureing dental procedure.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient and dentist satisfaction by using remifentanil in intravenous sedation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Respiratory rate is maintained more than 9 breaths/min. The dose of midazolam and propofol were titrated according to the OAA/S Scale (Observers Assessment of Alertness/Sedation Scale).
Interventions/Control_2
In addition to Intervention 1, remifentanil(0.06micro-g/kg/min)is additionally infused.
Interventions/Control_3
In addition to Intervention 1, remifentanil(0.08micro-g/kg/min)is additionally infused.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Physical status of the enrolled patients are American Society of Anesthesiologists(ASA) class 1-2, aged 20 years old or above, who cannot torelate dental treatment because of gag reflex.
Key exclusion criteria
Exclusion criteria included allergies to remifentanil, fentanyl-related, propofol and midazolam, used than other analgesic drug and sedative drug propofol and remifentanil, ASA class 3 or over, child and disability person.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mutsumi Nonaka |
Organization
Showa University School of Dentistry
Division name
Depertment of perioperative Medicine, Division of Anesthesiology
Zip code
Address
2-1-1 Kitasenzoku, Ota-ku, Tokyo
TEL
03-3787-1151
nmutsumi@dent.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mutsumi Nonaka |
Organization
Showa University School of Dentistry
Division name
Depertment of perioperative Medicine, Division of Anesthesiology
Zip code
Address
2-1-1 Kitasenzoku, Ota-ku, Tokyo
TEL
03-3787-1151
Homepage URL
nmutsumi@dent.showa-u.ac.jp
Sponsor or person
Institute
Depertment of perioperative Medicine, Division of Anesthesiology,Showa University School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2017 | Year | 04 | Month | 01 | 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
| 2014 | Year | 03 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 08 | 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
| 2017 | Year | 01 | Month | 30 | Day |
Last modified on
| 2017 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016578
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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