The efficacy and safety of remimazolam and propofol
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0008667
- Lead Sponsor
- Yonsei University Health System, Gangnam Severance Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 394
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of cardiopulmonary hazards at all times during the procedure
- Secondary Outcome Measures
Name Time Method Procedure time, recovery time, patient satisfaction, operator satisfaction, total remimazolam administered and propofol dose