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

This study has been completed.
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00164996
First received: September 10, 2005
Last updated: February 16, 2012
Last verified: September 2005
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Comparison of Ultrathin Versus Conventional Esophagogastroduodenoscopy in Unsedated Patients With or Without Local Pharyngeal Anaesthesia: A Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

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
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
  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

Locations
China
The Chinese University of Hong Kong
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Wilfred Lik-Man Mui, MD Chinese University of Hong Kong
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00164996     History of Changes
Other Study ID Numbers: CRE 2004.312
Study First Received: September 10, 2005
Last Updated: February 16, 2012
Health Authority: Hong Kong: Department of Health

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

Additional relevant MeSH terms:
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013