NCT05810532Completed
NPO Before Sedation
Investigation on the Safety of 4-1 Hour Fasting Policy Before Sedation in Children.
Source: ClinicalTrials.gov · Last updated 3 Apr 2024
Brief summary (registry, in English)
Pre-procedural fasting is routinely conducted to prevent pulmonary aspiration regarding sedation or anesthesia. However, prolonged fasting cause hypoglycemia, dehydration, nausea, and patient discomfort. Moreover, because children have small reserved energy, prolonged fasting need to be prohibited. Therefore, this study is designed to investigate the safety and efficacy of new fasting policy allowing water until 1 hour before sedation compared to the standard fasting time (4 hours of fasting including water).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 68 (actual)
- First submitted
- 31 Mar 2023
- Start date
- 4 May 2023
- Primary completion date
- 11 Dec 2023
- Lead sponsor
- Kangbuk Samsung Hospital
- NCT number
- NCT05810532
What you commit to
- Study type: Interventional
- Participants enrolled: 68
- From 4 May 2023 to the primary completion date, 11 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Comorbidity other than hear disease or chromosomal disease
Other
- Patients with delayed gastric emptying
- Patients with structural abnormalities of the stomach or esophagus
- Difficult airway management
- Parents refuse to participate in the study
- Unable to achieve sedation
- Neonatal
Who the study is looking for
- Children scheduled for elective echocardiography
- Aged under 3 years old
Age in the registry: 1 month to 3 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kangbuk Samsung Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.