NPO Before Sedation

April 1, 2024 updated by: Eunah Cho, MD, Kangbuk Samsung Hospital

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 4H group
fasting more than 4 hours before sedation
Other: 4 hours of fasting time
Oral intake is not allowed for 4 hours before sedation including water
Experimental: 1H group
oral hydration (water) is allowed 1 hour before sedation, while other food must be fasted more than 4 hours before sedation
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric astral cross-sectional area
Time Frame: 10 minutes before sedation
Gastric astral cross-sectional area measured with gastric ultrasound
10 minutes before sedation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Estimated gastric volume
Time Frame: 10 minutes before sedation
Calculated gastric volume using the formula
10 minutes before sedation
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
10 minutes before sedation
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
10 minutes after sedation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kangbuk Samsung Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2023

Primary Completion (Actual)

December 11, 2023

Study Completion (Actual)

December 11, 2023

Study Registration Dates

First Submitted

March 31, 2023

First Submitted That Met QC Criteria

March 31, 2023

First Posted (Actual)

April 12, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • NPO1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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