UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059874 |
|---|---|
| Receipt number | R000068468 |
| Scientific Title | Safety of Depth-Adjusted Intravenous Sedation in Office-Based Aesthetic Surgery: A One-Month Prospective Study of 135 Consecutive Cases |
| Date of disclosure of the study information | 2025/11/25 |
| Last modified on | 2025/11/25 14:43:35 |
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Basic information
Public title
Safety of Depth-Adjusted Intravenous Sedation in Office-Based Aesthetic Surgery:
A One-Month Prospective Study of 135 Consecutive Cases
Acronym
Safety of Depth-Adjusted Intravenous Sedation in Office-Based Aesthetic Surgery:
A One-Month Prospective Study of 135 Consecutive Cases
Scientific Title
Safety of Depth-Adjusted Intravenous Sedation in Office-Based Aesthetic Surgery:
A One-Month Prospective Study of 135 Consecutive Cases
Scientific Title:Acronym
Safety of Depth-Adjusted Intravenous Sedation in Office-Based Aesthetic Surgery:
A One-Month Prospective Study of 135 Consecutive Cases
Region
| Japan |
Condition
Condition
Cosmetic (aesthetic) indications only; no pathological disease is targeted.
Examples:
Double eyelid surgery
Fat grafting
Lifting procedures
Liposuction
Rhinoplasty
Classification by specialty
| Anesthesiology | Plastic surgery | Aesthetic surgery |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to prospectively evaluate the safety and patient-reported outcomes of the Ultra-safe Method for Elective Depth-adjusted Anesthesia (UMEDA protocol) used for office-based aesthetic surgery.
Primary objectives include:
1:Incidence of major cardiopulmonary events
2:Patient satisfaction (5-point Likert scale)
Secondary objectives include intra-operative recall, recovery time, adverse symptoms, and willingness to undergo the same sedation again.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Major cardiopulmonary events
SpO2 < 93% lasting >= 30 seconds
Systolic blood pressure deviation > +/-30% from baseline
Need for urgent airway intervention
2. Patient satisfaction score (1-5)
Key secondary outcomes
Intra-operative recall (none / induction-or-emergence only / continuous to binary analysis)
Recovery time (anesthetic stop to exit)
Adverse symptoms (nausea, dizziness, dyspnea, unsteadiness, etc.)
Desire to receive the same sedation again (Yes/No)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing aesthetic surgery during the study period
ASA-PS I-II
Written informed consent obtained
Intravenous sedation performed using the UMEDA protocol
Key exclusion criteria
Refusal or inability to provide informed consent
Known allergy to propofol components (soybean/egg derivatives)
Severe cardiopulmonary or psychiatric disorders deemed inappropriate by investigators
Emergency cases
Target sample size
135
Research contact person
Name of lead principal investigator
| 1st name | Hiroo |
| Middle name | |
| Last name | Teranishi |
Organization
Tokyo Chuo Beauty Clinic, Umeda Osaka Ekimae Clinic
Division name
Director
Zip code
5300057
Address
3rd Floor, K's Square Building, 2-8-15 Sonezaki, Kita-ku, Osaka-city, Osaka, Japan
TEL
0354221566
kiuchi.reiko@tcb.or.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Matsumura |
Organization
Tokyo Chuo Beauty Clinic, Umeda Osaka Ekimae Clinic
Division name
Tokyo Chuo Beauty Clinic, Umeda Osaka Ekimae Clinic
Zip code
5300057
Address
3rd Floor, K's Square Building, 2-8-15 Sonezaki, Kita-ku, Osaka-city, Osaka, Japan
TEL
06-6147-2581
Homepage URL
dr.matsumura.keisuke@tcb.or.jp
Sponsor or person
Institute
Tokyo Chuo Beauty Clinic, Umeda Osaka Ekimae Clinic
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
TCB Academic Committee and IRB
Address
3rd Floor, K's Square Building, 2-8-15 Sonezaki, Kita-ku, Osaka-city, Osaka, Japan
Tel
06-6147-2581
irb@tcb.or.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
| 2025 | Year | 11 | Month | 25 | 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
135
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
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Methods
Sedation performed using the standardized UMEDA protocol
Propofol bolus 0.8-1.2 mg/kg; maintenance 3-5 mg/kg/h
Target MOAA/S score of 2-3
SpO2 intervention threshold at 93%
Prospective data collection using a structured CRF
Statistical analysis with logistic and linear regression (EZR v1.68)
Management information
Registered date
| 2025 | Year | 11 | Month | 25 | Day |
Last modified on
| 2025 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068468
