Adverse Events During Upper Gastrointestinal Endoscopy

• Conditions: Esophagus Cancer; Oesophagitis; Patients Need Upper Gastrointestinal Endoscopy; Peptic Ulcer; Gastric Cancer

• Registration Number: NCT01979549
• Lead Sponsor: RenJi Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-03
• Study First Submitted QC: 2013-11-03
• Study First Posted: 2013-11-08
• Status Verified: 2013-12
• Study Start: 2013-12
• Last Update Submitted: 2014-01-20
• Last Update Posted: 2014-01-22
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events	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.

Trial Locations

Locations (3)

Shanghai Pudong New Area People's Hospital; 🇨🇳 Shanghai, Shanghai, China

Shanghai Tongji Hospital; 🇨🇳 Shanghai, Shanghai, China

Renji hospital, School of Medicine, Shanghai Jiaotong University; 🇨🇳 Shanghai, Shanghai, China