UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042451 |
|---|---|
| Receipt number | R000048459 |
| Scientific Title | Evaluation of sedation level by using SedLine during intravenous sedation for dental treatment |
| Date of disclosure of the study information | 2020/11/16 |
| Last modified on | 2022/06/21 14:44:48 |
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Basic information
Public title
Evaluation of sedation level by using SedLine during intravenous sedation for dental treatment
Acronym
Evaluation of sedation level by using SedLine
Scientific Title
Evaluation of sedation level by using SedLine during intravenous sedation for dental treatment
Scientific Title:Acronym
Evaluation of sedation level by using SedLine
Region
| Japan |
Condition
Condition
Dental Caries, periodontal disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the suitable Patient State Index in intravenous sedation for dental treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient State Index at the start of dental treatment.
Key secondary outcomes
1)Average Patient State Index during dental treatment.
2)The estimated propofol concentration in target controlled infusion at the start of dental treatment.
3)Blood pressure, heart rate, and oxygen saturation during sedation.
4)Total amount of midazolam and propofol for sedation.
5)Amnesia during dental treatment.
6)Satisfaction with sedation.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients whose age is over 20 years.
2)Patients whose American Society of Anesthesiology physical state(ASA PS) is 1 or 2.
Key exclusion criteria
1)Patients who needed management by deep sedation.
2)Patients who taking centrally acting drugs, such as anti-epileptic drugs and/or antipsychotic drugs.
3)Patients who are contraindicated for the use of midazolam or propofol.
4)Patients who are judged to be inappropriate for study participation.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Higuchi |
Organization
Okayama University Hospital
Division name
Department of Dental Anesthesiology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama, Japan
TEL
086-235-6721
higuti@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Higuchi |
Organization
Okayama University Hospital
Division name
Department of Dental Anesthesiology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama-shi, Okayama, Japan
TEL
086-235-6721
Homepage URL
higuti@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Okayama University
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
The Ethics Committee of Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
Tel
086-235-6938
mae6605@adm.okayama-u.ac.jp
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
| 2020 | Year | 11 | Month | 16 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/jjdsa/50/2/50_91/_article/-char/ja
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jjdsa/50/2/50_91/_article/-char/ja
Number of participants that the trial has enrolled
26
Results
The mean (SD) and median (25th percentile, 75th percentile) Patient State Index (PSI) during dental treatment when sedation was maintained at the Modified Observer's Assessment of Alertness/Sedation score 3 or 4 were 72.7 (13.6) and 75 (65, 85), respectively. Twenty-four patients (92%) stated that the sedation provided was satisfactory.
Results date posted
| 2022 | Year | 05 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 04 | Month | 15 | Day |
Baseline Characteristics
1)Patients whose age is over 20 years.
2)Patients whose American Society of Anesthesiology physical state(ASA PS) is 1 or 2.
Participant flow
Patients who were scheduled to undergo dental treatment involving intravenous sedation were assessed for eligibility.
Adverse events
None
Outcome measures
The mean and median of PSI during sedation, sedation-related amnesia, and patient satisfaction with sedation were investigated.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 11 | Month | 13 | Day |
Last modified on
| 2022 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048459
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| Registered date | File name |
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