Tokyo, Nov. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059874) titled 'Safety of Depth-Adjusted Intravenous Sedation in Office-Based Aesthetic Surgery:
A One-Month Prospective Study of 135 Consecutive Cases' on Nov. 25.
Study Type:
Observational
Primary Sponsor:
Institute - Tokyo Chuo Beauty Clinic, Umeda Osaka Ekimae Clinic
Condition:
Condition - Cosmetic (aesthetic) indications only; no pathological disease is targeted.
Examples:
Double eyelid surgery
Fat grafting
Lifting procedures
Liposuction
Rhinoplasty
Classification by malignancy - Others
Genomic information - NO
Objective:
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
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 Size - 135
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068468
Disclaimer: Curated by HT Syndication.
