NCT01979549

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2013

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
23 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

January 22, 2014

Status Verified

December 1, 2013

Enrollment Period

1 year

First QC Date

November 3, 2013

Last Update Submit

January 20, 2014

Conditions

Patients Need Upper Gastrointestinal EndoscopyPeptic UlcerGastric CancerEsophagus CancerOesophagitis

Keywords

Adverse eventsUpper gastrointestinal endoscopySedation

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    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

Study Arms (2)

Sedation

patients underwent upper gastrointestinal endoscopy with sedation

non-sedation

patients underwent upper gastrointestinal endoscopy without sedation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who will undergo the upper gastrointestinal endoscopy

You may qualify if:

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

You may not qualify if:

  • Pregnant
  • Allergy to propofol or soybean or albumen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, 200065, China

RECRUITING

Renji hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Shanghai Pudong New Area People's Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Peptic UlcerStomach NeoplasmsEsophageal NeoplasmsEsophagitis

Condition Hierarchy (Ancestors)

Duodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEsophageal DiseasesGastroenteritis

Study Officials

  • Diansan Su, Doctor

    Renji Hospital, School of Medicine, Shanghai Jiaotong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Diansan Su, Doctor

CONTACT

0086-21-68383702diansansu@yahoo.com

Xiangrui Wang, Doctor

CONTACT

0086-21-68383198wangxr2010@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

November 3, 2013

First Posted

November 8, 2013

Study Start

December 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 22, 2014

Record last verified: 2013-12

Locations

CN(3)