NPO Before Sedation

NCT05810532 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2024-04-03

No results posted yet for this study

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).

Conditions

  • Pediatric ALL

Interventions

OTHER

4 hours of fasting time

Oral intake is not allowed for 4 hours before sedation including water

OTHER

1 hour of fasting time

Oral intake is not allowed for 4 hours before sedation, while water is allowed to intake before 1 hour of sedation

Sponsors & Collaborators

  • Kangbuk Samsung Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-04
Primary Completion
2023-12-11
Completion
2023-12-11

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05810532 on ClinicalTrials.gov