Propofol vs. Midazolam With Propofol for Sedative Endoscopy in Patients With Previous Paradoxical Reaction to Midazolam

DongGuk University

Status and phase: Completed; Phase 2

Conditions: Sedation; Endoscopy

Treatments: Drug: Midazolam; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT04072328

2018-02-011

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Propofol alone

Experimental group

Description:

Participants who receive propofol alone during sedative endoscopy.

Treatment:

Drug: Propofol

Midazolam with propofol

Active Comparator group

Description:

Participants who receive midazolam + propofol during sedative endoscopy.

Treatment:

Drug: Midazolam

Drug: Propofol