Propofol Versus Midazolam With Fentanyl for EGD Endomicroscopy

Not Applicable

Completed

• Conditions: Gastritis; Functional Dyspepsia
• Interventions: Drug: midazolam with fentanyl; Drug: propofol

• Registration Number: NCT01053871
• Lead Sponsor: Shandong University

Brief Summary

This trial aims to compare the endomicroscopic image quality and sedation efficacy of propofol or midazolam with fentanyl.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-12
• Study Start: 2010-01
• Study First Submitted: 2010-01-21
• Study First Submitted QC: 2010-01-21
• Study First Posted: 2010-01-22
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Last Update Submitted: 2011-06-13
• Last Update Posted: 2011-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• outpatients attending endomicroscopy
• able to give written informed consent

Exclusion Criteria

• GI tract malignancy
• coagulopathy
• acute upper digestive tract bleeding
• pregnancy or breast feeding
• allergy to fluorescein sodium
• impaired renal function

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	midazolam with fentanyl	sedation using midazolam with fentanyl
1	propofol	sedation using propofol

Primary Outcome Measures

Name	Time	Method
endomicroscopic image quality	3 months

Secondary Outcome Measures

Name	Time	Method
sedation efficacy outcomes,patient assessment,physician assessment	3 months

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China