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Propofol Versus Midazolam With Fentanyl for EGD Endomicroscopy

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ClinicalTrials.gov Identifier: NCT01053871
Recruitment Status : Completed
First Posted : January 22, 2010
Last Update Posted : June 14, 2011
Information provided by:

Study Description
Brief Summary:
This trial aims to compare the endomicroscopic image quality and sedation efficacy of propofol or midazolam with fentanyl.

Condition or disease Intervention/treatment
Gastritis Functional Dyspepsia Drug: propofol Drug: midazolam with fentanyl

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Study Start Date : January 2010
Primary Completion Date : May 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
sedation using propofol
Drug: propofol
conscious sedation using propofol
Experimental: 2
sedation using midazolam with fentanyl
Drug: midazolam with fentanyl
conscious sedation using midazolam with fentanyl

Outcome Measures

Primary Outcome Measures :
  1. endomicroscopic image quality [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. sedation efficacy outcomes,patient assessment,physician assessment [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01053871

China, Shandong
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, China
Sponsors and Collaborators
Shandong University
Study Director: Yanqing Li, PhD. MD. Department of Gastroenterology, Qilu Hospital, Shandong University
More Information

Responsible Party: Li-Yanqing, Department of Gastroenterology, Qilu Hospital, Shandong University
ClinicalTrials.gov Identifier: NCT01053871     History of Changes
Other Study ID Numbers: 2009SDU-QILU-G08
First Posted: January 22, 2010    Key Record Dates
Last Update Posted: June 14, 2011
Last Verified: December 2009

Keywords provided by Shandong University:

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action