NPO Before Sedation

Not Applicable

Completed

• Conditions: Pediatric ALL
• Interventions: Other: 4 hours of fasting time; Other: 1 hour of fasting time

• Registration Number: NCT05810532
• Lead Sponsor: Kangbuk Samsung Hospital

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-31
• Study First Submitted QC: 2023-03-31
• Study First Posted: 2023-04-12
• Study Start: 2023-05-04
• Primary Completion: 2023-12-11
• Study Completion: 2023-12-11
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4H group	4 hours of fasting time	fasting more than 4 hours before sedation
1H group	1 hour of fasting time	oral hydration (water) is allowed 1 hour before sedation, while other food must be fasted more than 4 hours before sedation

Primary Outcome Measures

Name	Time	Method
Gastric astral cross-sectional area	10 minutes before sedation	Gastric astral cross-sectional area measured with gastric ultrasound

Secondary Outcome Measures

Name	Time	Method
Estimated gastric volume	10 minutes before sedation	Calculated gastric volume using the formula
Quality of sdeation	10 minutes after sedation	0, no response to pain; 1, slight response to pain; 2, response to pain; 3, response to calling
Perlas grade	10 minutes before sedation	Perlas grade 0 : no risk of aspiration, Perlas grade 1 : minimal risk of aspiration, Perlas grade 2: high risk of aspiration

Trial Locations

Locations (1)

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of