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Completed

NCT Number: NCT05889637

Gastric Ultrasound Assessment for Preoperative Prandial State of Patients Taking Glucagon-Like Peptide-1 Receptor Agonists

The purpose of this study is to determine the type of gastric content and quantify the volume of liquid gastric contents using ultrasonography in patients on GLP-1 agonists that have presented for elective surgery and to determine if risk factors are associated with a higher gastric volume in patients on GLP-1 receptor agonists.

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Key information

Conditions

Pulmonary Aspiration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients taking GLP-1receptor agonists (N=62)
  • Patients not taking GLP-1 receptor agonists (N=62)

Exclusion criteria

  • Previous gastric resection or bypass
  • Gastric band in situ
  • Previous fundoplication
  • Large hiatal hernia
  • Pregnant patients
  • Recent trauma
  • Inability to turn to the right lateral decubitus position

Treatment and study plan

Gastric ultrasound

Diagnostic Test

Patient will be scanned first in the supine position and then in the right lateral decubitus position. The ultrasound probe will be placed in a sagittal plane in the epigastric region at the left subcostal margin and then will be moved past the midline in a fan like manner to the right subcostal region. Qualitative and quantitative assessments will be done.

Primary outcomes

  1. Number of subjects that are at risk for aspiration

    Time frame: end of ultrasound

    Risk for aspiration is indicated by the presence of solids, thick fluid, or clear fluids >1.5ml/kg in the gastric antrum in the right lateral decubitus position

  2. Number of subjects that are at low risk for aspiration

    Time frame: end of ultrasound

    Low risk for aspiration is indicated by a collapsed gastric antrum or clear fluids <1.5ml/kg in the gastric antrum in the right lateral decubitus position.

Secondary outcomes

  1. Age

    Time frame: end of ultrasound

  2. Number of participants that are male as indicated in the medical records

    Time frame: end of ultrasound

  3. Number of participants that are female as indicated in the medical records

    Time frame: end of ultrasound

  4. Body mass Index (BMI)

    Time frame: end of ultrasound

    Body Mass Index (BMI) is calculated as the body mass in kilograms (kg) divided by the square of the body height in meters, and is expressed in units of kg/m2.

  5. Physical status as assessed by the American Society of Anesthesiologists (ASA) physical status classification system

    Time frame: end of ultrasound

    The classification ranges from American Society of Anesthesiologists (ASA)1 (normal healthy person ) to ASA IV (A patient with severe systemic disease that is a constant threat to life)

  6. Number of participants with diabetes

    Time frame: end of ultrasound

  7. Number of participants with reported nothing by mouth (NPO) status

    Time frame: end of ultrasound

  8. Pain severity as assessed by the numeric scale

    Time frame: end of ultrasound

    This is a 11 point scale with scores ranging from 0 (no pain) to 10 (worst imaginable pain)

  9. Number of participants with Gastroesophageal reflux disease (GERD)

    Time frame: end of ultrasound

  10. Number of participants that have use opioids preoperatively

    Time frame: end of ultrasound

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

Gastric Ultrasound Assessment for Preoperative Prandial State of Patients Taking Glucagon-Like Peptide-1(GLP-1) Receptor Agonists

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 5, 2023
Registry last updated
Aug 2, 2023

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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