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Ultrathin Versus Conventional Esophagogastroduodenoscopy in Unsedated Patient With or Without Local Pharyngeal Anaesthesia

This study is currently recruiting participants.
Verified by Chinese University of Hong Kong, September 2005

Sponsored by: Chinese University of Hong Kong
Information provided by: Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00164996
  Purpose

The purpose of this study is to investigate whether an ultrathin endoscope will improve a patient's tolerance during the procedure. In addition, this study will look at whether local pharyngeal anaesthesia is necessary during ultrathin endoscopy.


Condition Intervention Phase
Dyspepsia
Procedure: Local pharyngeal anaesthesia
Device: Ultrathin endoscope
Phase III

MedlinePlus related topics:   Anesthesia    Endoscopy    Indigestion   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment
Official Title:   Comparison of Ultrathin Versus Conventional Esophagogastroduodenoscopy in Unsedated Patients With or Without Local Pharyngeal Anaesthesia: A Randomized Controlled Trial

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • patient's tolerance and anxiety in visual analog scale (VAS) score

Secondary Outcome Measures:
  • patient's satisfaction; procedure time; complications

Estimated Enrollment:   400
Study Start Date:   September 2004

  Eligibility
Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Aged between 18-70

Exclusion Criteria:

  • Previous experience of upper endoscopy
  • Allergy to local pharyngeal anaesthesia
  • Patient requesting sedation during endoscopy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00164996

Contacts
Contact: Wilfred Lik-Man Mui, MD     852-26322627     wilfredmui@hotmail.com    

Locations
China
The Chinese University of Hong Kong     Recruiting
      Hong Kong, China
      Contact: Department of Surgery , MD     852-26322627     wilfredmui@hotmail.com    

Sponsors and Collaborators
Chinese University of Hong Kong

Investigators
Principal Investigator:     Wilfred Lik-Man Mui, MD     Chinese University of Hong Kong    
  More Information


Study ID Numbers:   CRE 2004.312
First Received:   September 10, 2005
Last Updated:   August 23, 2007
ClinicalTrials.gov Identifier:   NCT00164996
Health Authority:   Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:
upper endoscopy  
local pharyngeal anaesthesia  
ultrathin endoscope  

Study placed in the following topic categories:
Signs and Symptoms
Signs and Symptoms, Digestive
Dyspepsia

ClinicalTrials.gov processed this record on October 24, 2008




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