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CompletedNCT03019341Updated Apr 26, 2017

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

An observational study in Contrast Agent and Nausea, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-04-26.

Sponsored by Seoul National University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,175
Ages
20 Years and older
Sex
All
01

Study summary

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.

Read the 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.

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Conditions studied

  • Contrast Agent
  • Nausea

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Keywords

  • Nausea
  • Vomiting
  • Non-ionic contrast media
  • Side effect
03

In context

Nausea

822 studies on the registry are indexed under Nausea; 104 are open to participants now.

This study's enrollment of 1,175 is above the median of 170 across 90 observational studies indexed under Nausea.

Browse Nausea studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,175 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Patients with enhanced CT scan

    Patients undergo CT examination after the administration of non-ionic contrast media for clinical need.

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What researchers measure

Primary outcomes

  1. Prevalence of immediate nausea or vomiting after contrast injection

    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.

    Time frame: For 30 minutes after administration of non-ionic contrast media

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Study locations

1 site
  • Seoul National University Hospital
    Seoul, 03080, Korea, Republic of
08

References and documents

Publications

  • Lee BY, Ok JJ, Abdelaziz Elsayed AA, Kim Y, Han DH. Preparative fasting for contrast-enhanced CT: reconsideration. Radiology. 2012 May;263(2):444-50. doi: 10.1148/radiol.12111605. PubMed 22517959 ↗
  • Federle MP, Willis LL, Swanson DP. Ionic versus nonionic contrast media: a prospective study of the effect of rapid bolus injection on nausea and anaphylactoid reactions. J Comput Assist Tomogr. 1998 May-Jun;22(3):341-5. doi: 10.1097/00004728-199805000-00001. PubMed 9606371 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03019341
Lead sponsor
Seoul National University Hospital
Responsible party
Soon Ho Yoon (Assistant professor, Department of Radiology, Seoul National University Hospital, Seoul National University Hospital) — Principal investigator
First posted
Jan 12, 2017
Start date
Jan 1, 2017
Primary completion
Mar 31, 2017
Completion
Mar 31, 2017
Last update
Apr 26, 2017

Study contacts

Soon ho Yoon
study chair · Seoul National University of Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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