Clinical trial NCT03019341: Immediate Nausea and Vomiting After the Administration of Non-ionic Contrast Media
Official title: Immediate Nausea and Vomiting After the Administration of Non-ionic Contrast Media: Prevalence and Risk Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contrast Agent
Nausea
Keywords: Nausea
Vomiting
Non-ionic contrast media
Side effect
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-01-12
Enrollment: 1175
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility 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:

* 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.

Primary outcomes:
measure: Prevalence of immediate nausea or vomiting after contrast injection
timeFrame: For 30 minutes after administration of non-ionic contrast media
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University of Hospital
name: Soon ho Yoon
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.