Premedication Gastric Ultrasound

August 19, 2025 updated by: Kevin Spellman

Ultrasound Assessment of Gastric Volume After Drinking Premedication: A Prospective Descriptive Study

The primary objective of this study is to assess gastric volume in fasted children using ultrasound before and after drinking premedication. The hypothesis is that the qualitative and quantitative assessment by gastric ultrasound in the stomach before and after drinking premedication will be the same as premedication has a small volume.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

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

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

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

1 second to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ASA 1-2 patients aged 0-18 years of scheduled for elective surgery under general anesthesia.

Exclusion Criteria:

  • Patients who are not adhere to institutional fasting guidelines.

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: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Fasted Children
Device: Point-of-Care Ultrasound
Portable ultrasonography done at the bedside.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Qualitative and Quantitative Gastric Assessment After Premedication
Time Frame: Ultrasound scan performed at baseline (before surgery) to measure gastric volume and 3 minutes after taking premedication to assess change.
Gastric volume in fasted children before and after drinking premedication. Gastric volume in pediatric patients is estimated by the model: GV= -7.8 + (3.5× RLD CSA) + (0.127) × age (months).
Ultrasound scan performed at baseline (before surgery) to measure gastric volume and 3 minutes after taking premedication to assess change.

Collaborators and Investigators

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

Sponsor

Kevin Spellman

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)

August 18, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

October 14, 2019

First Submitted That Met QC Criteria

October 16, 2019

First Posted (Actual)

October 17, 2019

Study Record Updates

Last Update Posted (Actual)

August 24, 2025

Last Update Submitted That Met QC Criteria

August 19, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00000586

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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