NPO Before Sedation

Kangbuk Samsung Hospital

Status: Completed

Conditions: Pediatric ALL

Treatments: Other: 4 hours of fasting time; Other: 1 hour of fasting time

Study type: Interventional

Funder types: Other

Identifiers

NCT05810532

NPO1

Details and patient eligibility

About

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).

Enrollment: 68 patients

Sex: All

Ages: 1 month to 3 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children scheduled for elective echocardiography
• Aged under 3 years old

Exclusion criteria

• Comorbidity other than hear disease or chromosomal disease
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups

4H group

Active Comparator group

Description:

fasting more than 4 hours before sedation

Treatment:

Other: 4 hours of fasting time

1H group

Experimental group

Description:

oral hydration (water) is allowed 1 hour before sedation, while other food must be fasted more than 4 hours before sedation

Treatment:

Other: 1 hour of fasting time