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The efficacy and safety of remimazolam and propofol

Comparison of efficacy and safety of remimazolam and propofol: multicenter prospective randomized trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008667
Enrollment
394
Registered
2023-08-01
Start date
2023-06-26
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

None listed

Interventions

Sponsors

Yonsei University Health System, Gangnam Severance Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Men or women between the ages of 20 and 70 2) Subjects who have voluntarily decided to participate after hearing the explanation of the clinical trial process and signed the consent form 3) All subjects requiring ultrasound endoscopy 4) Subjects with class I or II in the American Society of Anesthesiology (ASA) risk assessment

Exclusion criteria

Exclusion criteria: 1) Pregnant woman 2) Those who are susceptible to remimazolam, propofol or benzodiazepine drugs (midazolam), or those who are susceptible to eggs, beans, etc 3) subjects undergoing adrenocortical or chronic steroid therapy or porphyria 4) Subjects who are expected to have difficulty with airway intubation (subjects who have difficulty opening their mouths wide or have a thick neck and short neck) 5) a subject diagnosed with sleep apnea 6) Subjects with a history of reported risk cases during sedative endoscopy in the past 7) Subjects with severe renal disease (serum creatinine >2 mg/dL) 8) Subjects with severe heart disease (subjects with NYHA class III or IV) 9) subjects who wish to receive an endoscopy without sincerity 10) Subjects who cannot or are not willing to prepare an automatic test protocol or who do not agree to provide information; 11) Subjects whose oxygen saturation is less than 90% or less than 95% despite the oxygen supply of 2 L/min 12) Subjects with an underlying systolic blood pressure of less than 80 mmHg

Design outcomes

Primary

MeasureTime frame
Frequency of cardiopulmonary hazards at all times during the procedure

Secondary

MeasureTime frame
Procedure time, recovery time, patient satisfaction, operator satisfaction, total remimazolam administered and propofol dose

Countries

Korea, Republic of

Contacts

Public ContactDongwook Oh

Asan Medical Center

wooki219@naver.com+82-2-3010-3189

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026