Immediate Nausea and Vomiting After the Administration of Non-ionic Contrast Media

April 24, 2017 updated by: Soon Ho Yoon, Seoul National University Hospital

Immediate Nausea and Vomiting After the Administration of Non-ionic Contrast Media: Prevalence and Risk Factors

The prevalence of nausea and vomiting after the administration of non-ionic contrast media has rarely been assessed. Thus, the aim of our study is to evaluate the prevalence and risk factors of nausea and vomiting after the exposure to the non-ionic contrast media for computed tomography examinations in adults.

Study Overview

Status

Completed

Conditions

Detailed Description

There is no robust evidence or guideline for fasting prior to contrast-enhanced CT scan in patients. Substantial heterogeneity exists on fasting prior to contrast-enhanced CT worldwide. Through dedicated questionnaires, the investigators plan to prospectively assess the prevalence and the risk factors for nausea and vomiting after the exposure to the non-ionic contrast media agent in adult patients undergoing computed tomography examinations.

Study Type

Observational

Enrollment (Actual)

1175

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

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who undergo elective CT examination after the administration of non-ionic contrast media in a single tertiary hospital will be enrolled based on following inclusion and exclusion criteria.

Description

Inclusion criteria:

  • Patients undergoing contrast-enhanced CT examination with non-ionic contrast media during regular working hours
  • Adult patients (20 years old or older)
  • Patients with informed written consent
  • Patients under observation by medical staffs during and after CT examination up to 30 minutes.

Exclusion criteria:

  • Patients without informed written consent
  • Age of patients younger than 20 years old
  • Uncooperative patients
  • Pediatric, pregnant, and emergent patients
  • Patients without sufficient observation by medical staffs during and after CT examination up to 30 minutes.

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

Cohorts and Interventions

Group / Cohort
Patients with enhanced CT scan
Patients undergo CT examination after the administration of non-ionic contrast media for clinical need.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of immediate nausea or vomiting after contrast injection
Time Frame: For 30 minutes after administration of non-ionic contrast media
Patients will be observed for 30 minutes after the administration of the contrast media agent and medical staffs will record and evaluate the patients' status and the severity of gastrointestinal reaction to the contrast media agent such as nausea or vomiting.
For 30 minutes after administration of non-ionic contrast media

Collaborators and Investigators

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

Investigators

  • Study Chair: Soon ho Yoon, Seoul National University of Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Actual)

January 1, 2017

Primary Completion (Actual)

March 31, 2017

Study Completion (Actual)

March 31, 2017

Study Registration Dates

First Submitted

December 31, 2016

First Submitted That Met QC Criteria

January 10, 2017

First Posted (Estimate)

January 12, 2017

Study Record Updates

Last Update Posted (Actual)

April 26, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SeoulNUH_NVICM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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