Adverse Events During Upper Gastrointestinal Endoscopy (AEDUGESSH)

January 20, 2014 updated by: diansan su, RenJi Hospital

Adverse Events During Upper Gastrointestinal Endoscopy With and Without Sedation: a Multiple Center Report From Shanghai

The primary objective is to investigate the adverse events during upper gastrointestinal endoscopy with and without sedation in Chinese population

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

6000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- Shanghai
  - Shanghai, Shanghai, China, 200065
    - Recruiting
    - Shanghai Tongji Hospital
    - Principal Investigator:
      
      Xiaoqing Zhang, M.S.
  - Shanghai, Shanghai, China, 200127
    - Recruiting
    - Renji Hospital, School of Medicine, Shanghai Jiaotong University
    - Contact:
      
      Diansan Su, Doctor
      
      Phone Number: 0086-21-68383702
      
      Email: diansansu@yahoo.com
    - Principal Investigator:
      
      Diansan Su, Doctor
  - Shanghai, Shanghai, China
    - Recruiting
    - Shanghai Pudong New Area People's Hospital
    - Contact:
      
      Lizhi Li, M.S.
      
      Email: Fmlilizhi@sina.com.cn
    - Principal Investigator:
      
      Lizhi Li, M.S.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who will undergo the upper gastrointestinal endoscopy

Description

Inclusion Criteria:

Patients will undergo upper gastrointestinal endoscopy
Age > 18 years old
Signed informed consent form

Exclusion Criteria:

Pregnant
Allergy to propofol or soybean or albumen

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Sedation patients underwent upper gastrointestinal endoscopy with sedation
non-sedation patients underwent upper gastrointestinal endoscopy without sedation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events Time Frame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours	Investigate the adverse events according to the Adverse event reporting tool of the world SIVA International Sedation Task Force during upper gastrointestinal endoscopy with and without sedation.	Patients will be followed for the duration of hospital stay, an expected average of 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Collaborators

Shanghai Tongji Hospital, Tongji University School of Medicine

Shanghai Pudong New Area People's Hospital

Investigators

Principal Investigator: Diansan Su, Doctor, Renji Hospital, School of Medicine, Shanghai Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

November 3, 2013

First Submitted That Met QC Criteria