Propofol vs. Midazolam With Propofol for Sedative Endoscopy in Patients With Previous Paradoxical Reaction to Midazolam
Overview
- Phase
- Phase 2
- Intervention
- Midazolam
- Conditions
- Sedation
- Sponsor
- DongGuk University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- The prevalence of paradoxical response
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Dong Kee Jang
Assistant Professor
DongGuk University
Eligibility Criteria
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
Arms & Interventions
Midazolam with propofol
Participants who receive midazolam + propofol during sedative endoscopy.
Intervention: Midazolam
Propofol alone
Participants who receive propofol alone during sedative endoscopy.
Intervention: Propofol
Midazolam with propofol
Participants who receive midazolam + propofol during sedative endoscopy.
Intervention: Propofol
Outcomes
Primary Outcomes
The prevalence of paradoxical response
Time Frame: At the end of endoscopy
The proportion of participants who show paradoxical response during endoscopy