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Safety of Depth-Adjusted Intravenous Sedation in Office-Based Aesthetic Surgery: A One-Month Prospective Study of 135 Consecutive Cases

Safety of Depth-Adjusted Intravenous Sedation in Office-Based Aesthetic Surgery: A One-Month Prospective Study of 135 Consecutive Cases - Safety of Depth-Adjusted Intravenous Sedation in Office-Based Aesthetic Surgery: A One-Month Prospective Study of 135 Consecutive Cases

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000059874
Enrollment
135
Registered
2025-11-25
Start date
2025-05-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cosmetic (aesthetic) indications only

Interventions

None listed

Sponsors

Tokyo Chuo Beauty Clinic, Umeda Osaka Ekimae Clinic
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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)

Secondary

MeasureTime frame
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)

Countries

Japan

Contacts

Public ContactKeisuke Matsumura

Tokyo Chuo Beauty Clinic, Umeda Osaka Ekimae Clinic Tokyo Chuo Beauty Clinic, Umeda Osaka Ekimae Clinic

dr.matsumura.keisuke@tcb.or.jp06-6147-2581

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026