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

NCT03019341 | Completed

• 1 other identifier: SeoulNUH_NVICM
• Study Type: observational
• Target: 1,175
• Locations: 1 country
• Sites: 1

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.

Conditions

Contrast Agent; Nausea

Keywords

Nausea; Vomiting; Non-ionic contrast media; Side effect

Outcome Measures

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.

  For 30 minutes after administration of non-ionic contrast media

Study Arms (1)

Patients with enhanced CT scan

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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (2)

• 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.

  PMID: 22517959 BACKGROUND

• 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.

  PMID: 9606371 BACKGROUND

MeSH Terms

Conditions

Nausea; Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Soon ho Yoon

  Seoul National University of Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor, Department of Radiology, Seoul National University Hospital

Study Record Dates

• First Submitted: December 31, 2016
• First Posted: January 12, 2017
• Study Start: January 1, 2017
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: April 26, 2017

Record last verified: 2017-04

Locations

KR (1)