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Clinical Trials/NCT05889637
NCT05889637
Completed
Not Applicable

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

The University of Texas Health Science Center, Houston1 site in 1 country132 target enrollmentJune 6, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Aspiration
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
132
Locations
1
Primary Endpoint
Number of subjects that are at risk for aspiration
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 6, 2023
End Date
July 12, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sudipta Sen

Assisstant Professor

The University of Texas Health Science Center, Houston

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

  • Age(end of ultrasound)
  • Number of participants with Gastroesophageal reflux disease (GERD)(end of ultrasound)
  • Body mass Index (BMI)(end of ultrasound)
  • Physical status as assessed by the American Society of Anesthesiologists (ASA) physical status classification system(end of ultrasound)
  • Number of participants with reported nothing by mouth (NPO) status(end of ultrasound)
  • Number of participants that have use opioids preoperatively(end of ultrasound)
  • Number of participants with diabetes(end of ultrasound)
  • Number of participants that are male as indicated in the medical records(end of ultrasound)
  • Number of participants that are female as indicated in the medical records(end of ultrasound)
  • Pain severity as assessed by the numeric scale(end of ultrasound)

Study Sites (1)

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