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Completed

NCT Number: NCT05810532

NPO Before Sedation

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).

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Key information

Conditions

Pediatric ALL Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

1 month–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4 hours of fasting time

Other

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

1 hour of fasting time

Other

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

Primary outcomes

  1. Gastric astral cross-sectional area

    Time frame: 10 minutes before sedation

    Gastric astral cross-sectional area measured with gastric ultrasound

Secondary outcomes

  1. Estimated gastric volume

    Time frame: 10 minutes before sedation

    Calculated gastric volume using the formula

  2. Perlas grade

    Time frame: 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

  3. Quality of sdeation

    Time frame: 10 minutes after sedation

    0, no response to pain; 1, slight response to pain; 2, response to pain; 3, response to calling

Sponsors and collaborators

Lead sponsor

Kangbuk Samsung Hospital

Other

Registry information

Official study title

Investigation on the Safety of 4-1 Hour Fasting Policy Before Sedation in Children.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 12, 2023
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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