Propofol Versus Midazolam With Fentanyl for EGD Endomicroscopy

NCT ID: NCT01053871

Last Updated: 2011-06-14

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-05-31

Brief Summary

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

Detailed Description

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Conditions

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Gastritis Functional Dyspepsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

sedation using propofol

Group Type EXPERIMENTAL

propofol

Intervention Type DRUG

conscious sedation using propofol

2

sedation using midazolam with fentanyl

Group Type EXPERIMENTAL

midazolam with fentanyl

Intervention Type DRUG

conscious sedation using midazolam with fentanyl

Interventions

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propofol

conscious sedation using propofol

Intervention Type DRUG

midazolam with fentanyl

conscious sedation using midazolam with fentanyl

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Department of Gastroenterology, Qilu Hospital, Shandong University

Principal Investigators

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Yanqing Li, PhD. MD.

Role: STUDY_DIRECTOR

Department of Gastroenterology, Qilu Hospital, Shandong University

Locations

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Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status

Countries

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China

Other Identifiers

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2009SDU-QILU-G08

Identifier Type: -

Identifier Source: org_study_id

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