Propofol vs. Midazolam With Propofol for Sedative Endoscopy in Patients With Previous Paradoxical Reaction to Midazolam
- Registration Number
- NCT04072328
- Lead Sponsor
- DongGuk University
- Brief Summary
This study is to compare propofol vs. midazolam with propofol for sedative endoscopy in patients with previous paradoxical reaction to midazolam. Patients who meet eligibility criteria will randomly assigned to propofol group or midazolam with propofol group. Then they will receive a sedative endoscopy with close monitoring. The primary outcome is the prevalence of paradoxical response during endoscopy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- History of midazolam-induced paradoxical response
Exclusion Criteria
- Failed to obtain informed consent
- Pregnant or breast feeding women
- A severe cardiopulmonary or vascular disease with symptoms
- Cognitive or mental impairment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Propofol alone Propofol Participants who receive propofol alone during sedative endoscopy. Midazolam with propofol Propofol Participants who receive midazolam + propofol during sedative endoscopy. Midazolam with propofol Midazolam Participants who receive midazolam + propofol during sedative endoscopy.
- Primary Outcome Measures
Name Time Method The prevalence of paradoxical response At the end of endoscopy The proportion of participants who show paradoxical response during endoscopy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Dongguk University Ilsan Hospital
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of