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Completed

NCT Number: NCT01053871

Propofol Versus Midazolam With Fentanyl for EGD Endomicroscopy

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

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Key information

Conditions

Gastritis Digestive System Diseases Functional Dyspepsia Gastroenteritis Gastrointestinal Diseases Stomach Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propofol

Drug

conscious sedation using propofol

midazolam with fentanyl

Drug

conscious sedation using midazolam with fentanyl

Primary outcomes

  1. endomicroscopic image quality

    Time frame: 3 months

Secondary outcomes

  1. sedation efficacy outcomes,patient assessment,physician assessment

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 22, 2010
Registry last updated
Jun 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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