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Propofol Versus Midazolam With Fentanyl for EGD Endomicroscopy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01053871
First Posted: January 22, 2010
Last Update Posted: June 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shandong University
  Purpose
This trial aims to compare the endomicroscopic image quality and sedation efficacy of propofol or midazolam with fentanyl.

Condition Intervention
Gastritis Functional Dyspepsia Drug: propofol Drug: midazolam with fentanyl

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)

Resource links provided by NLM:


Further study details as provided by Shandong University:

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

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

Estimated Enrollment: 104
Study Start Date: January 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Criteria

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
Information from the National Library of Medicine

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


Locations
China, Shandong
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, China
Sponsors and Collaborators
Shandong University
Investigators
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 Submitted: January 21, 2010
First Posted: January 22, 2010
Last Update Posted: June 14, 2011
Last Verified: December 2009

Keywords provided by Shandong University:
normal

Additional relevant MeSH terms:
Dyspepsia
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Propofol
Midazolam
Fentanyl
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
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