Remimazolam Versus Midaszolam for Sedation in Diagnostic Upper Gastrointestinal Endoscopy
NCT ID: NCT05836545
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
132 participants
INTERVENTIONAL
2023-04-05
2024-01-06
Brief Summary
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* Superiority of total procedure time in remimazolam compared to midazolam
* The success of sedation time
This is the single blind study.; Patients will not know what they are given as the sedation drug If there is a comparison group: Researchers will compare patients with midazolam group to see if remimazolam group is superior to midazolam group
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Midazolam
The patient with midazolam
Midazolam
The patient with midazolam
Remimazolam
The patient with remimazolam
Remimazolam
The patient with remimazolam
Interventions
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Remimazolam
The patient with remimazolam
Midazolam
The patient with midazolam
Eligibility Criteria
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Inclusion Criteria
* Patients who want diagnostic endoscopy under sedation
* The total procedure time which is predicted within 15 minutes
* ASA \>=2
* BMI more than 18.5kg/m2, less than 30kg/m2
Exclusion Criteria
* Patients with respiratory disease
* Mallampati Score\>=3
* Systolic BP \>160mmHg or \<90mmHg
* Refractory Hypertension
* Uncontrolled glaucoma
* Severe liver failure or chronic kidney disease
* Patients with drug abuse or alcohol abuse within 1 year
* Patients who are sensitive for certain medication (such as benzodiazepine, remimazolam)
* Obstructive sleep dyspnea patients
* Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
* Pregnant, breast feeding patient
18 Years
60 Years
ALL
Yes
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Principal Investigators
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Taejun Kim
Role: STUDY_DIRECTOR
Samsung Medical Center
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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2022-08-2391
Identifier Type: -
Identifier Source: org_study_id
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