None listed
Conditions
Brief summary
This randomized study aims to evaluate the incidence of nausea, vomiting, and other acute adverse reactions associated with the intravenous administration of non-ionic contrast media in outpatients undergoing non-emergency contrast-enhanced CT and to identify potential risk factors for the occurrence of these acute adverse reactions. Preparatory fasting prior to contrast-enhanced CT studies may be unnecessary.
Interventions
This study involves non-hospitalized subjects, aged 18 years or older, who are refer to the radiology department for a non-emergency contrast-enhanced computed tomography (CT) during regular working hours on a weekday at our hospital (Monday to Friday, from 08:30 to 15:00). Participants will be approached by their physicians and upon their acceptance to participate in the study, written consent will be obtain. Participants will be randomly assigned to either the intervention arm (unrestricted consumption of solids up to the time of the CT) or the control group (solid food fasting). There will be no fluids and/or medication ingestion restriction for any arm of the study. The subjects will be notified about their assignment arm (fasting or non-fasting) by the department nurses the week before the CT scan. A record sheet self-designed by our group will be used to register the date of examination, basic information of the patients (gender, age, body weight, height and body mass index), the fasting status (fasted or non-fasted participant), the intravenous contrast media induced adverse reactions history and other allergy history, underlying diseases, the examination parts, the name, dose and injection rate of ICMs and the occurrence condition, occurrence time, accompanying symptoms and outcome of ADR. Full-time nurses will assess and screen the patient’s item by item according to the sheet contents, completed and archived them. Five 64 multidetector CT scans will be used. Different imaging protocols will be followed depending on the clinical indication or anatomic region examined (head and neck, chest, abdominopelvic and vascular). All contrast-enhanced CT examinations will be performed with one single type of intravenous nonionic contact media injected by a high-pressure injector using a 18, 20 and 22 G needle. The intravenous injection rate will be 1 to 5 ml/s. The contrast media to be used will be Ioversol at the concentration of 300, 320 and 350 mg iodine per milligram according to the purpose of the CT scan, based on our institutional. protocol. The time of the intravenous contrast media administration before the CT examination will depend on the purpose of the examination. The injection doses and rates of contrast media will be selected according to the patient weight and the purpose of CT examinations, based on our institutional protocol. The duration of the CT scan will vary according to the purpose of the examination and the discretion of the radiologist.
Sponsors
Study design
Eligibility
Inclusion criteria
Patients must be scheduled for a non-emergency contrast-enhanced CT scan during weekdays and be equal to or older than 18 years in order to participate in the study.
Exclusion criteria
Incomplete form data filling, presence of intravenous contrast extravasation, intake of antiemetic and prokinetic medication 8 to 12 hours before the examination, patients with overt hyperthyroidism, history of allergic reaction or hypersensitivity to iodinated contrast media and patients unable to provide written informed consent.