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

Nausea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03019341
• Other study ID #: SeoulNUH_NVICM
• Status: Completed
• Phase: N/A
• First received: December 31, 2016
• Last updated: April 24, 2017
• Start date: January 1, 2017
• Est. completion date: March 31, 2017

Study information

• Verified date: April 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1175
• Est. completion date: March 31, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Contrast Agent
• Nausea
• Vomiting

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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