Propofol Versus Midazolam With Fentanyl for EGD Endomicroscopy

This study has been completed.
Sponsor:
Information provided by:
Shandong University
ClinicalTrials.gov Identifier:
NCT01053871
First received: January 21, 2010
Last updated: June 13, 2011
Last verified: December 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)

Resource links provided by NLM:


Further study details as provided by Shandong University:

Primary Outcome Measures:
  • endomicroscopic image quality [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • sedation efficacy outcomes,patient assessment,physician assessment [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 21, 2010
Last Updated: June 13, 2011
Health Authority: China: Ministry of Health

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
Midazolam
Fentanyl
Propofol
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics

ClinicalTrials.gov processed this record on August 20, 2014