UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062191 |
|---|---|
| Receipt number | R000071119 |
| Scientific Title | Clinical Utility of Capnography during Implant Surgery under Intravenous Sedation |
| Date of disclosure of the study information | 2026/07/09 |
| Last modified on | 2026/07/09 19:16:25 |
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Basic information
Public title
Clinical Utility of Capnography during Implant Surgery under Intravenous Sedation
Acronym
Clinical Utility of Capnography during Implant Surgery under Intravenous Sedation
Scientific Title
Clinical Utility of Capnography during Implant Surgery under Intravenous Sedation
Scientific Title:Acronym
Clinical Utility of Capnography during Implant Surgery under Intravenous Sedation
Region
| Japan |
Condition
Condition
Patients receiving intravenous sedation during implant-related surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the usefulness of capnometers in implant-related surgeries under intravenous sedation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of times SpO2 fell below 95%
Key secondary outcomes
Number of respiratory interventions
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Connect a capnometer and observe respiration in real time.
Interventions/Control_2
If apnea is detected by the capnometer, respiratory intervention will be performed.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligible patients meet the criteria of the American Society of Anesthesiologists(ASA) physical status of I-II.
Key exclusion criteria
Eligible patients meet the criteria of the American Society of Anesthesiologists(ASA) physical status of 3-5.
Patients without consent.
Patients whose SpO2 is 95% or less during daily activities.
Patients with a BMI of 30 kg/m2 or higher.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yuna |
| Middle name | |
| Last name | Kang |
Organization
Tokyo Dental College
Division name
Dental Anesthesiology
Zip code
101-0061
Address
2-9-18 Misakicho,Chiyodaku,Tokyo-to 101-0061 Japan
TEL
03-6380-9001
yunakang@tdc.ac.jp
Public contact
Name of contact person
| 1st name | Yuna |
| Middle name | |
| Last name | Kang |
Organization
Tokyo Dental College
Division name
Dental Anesthesiology
Zip code
101-0061
Address
2-9-18 Misakicho,Chiyodaku,Tokyo-to 101-0061 Japan
TEL
03-6380-9001
Homepage URL
yunakang@tdc.ac.jp
Sponsor or person
Institute
Tokyo Dental College
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Tokyo Dental College Ethics Review Board
Address
2-9-18 Misakicho,Chiyodaku,Tokyo-to 101-0061 Japan
Tel
03-6380-9001
drinri@tdc.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
| 2026 | Year | 07 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 09 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 09 | Day |
Last modified on
| 2026 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071119
