Recruiting

Observational Study

Sponsor:

University of Arkansas

Code:

NCT06814080

Conditions

Pre-op Gastric Emptying

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

Studies have shown that even following the fasting guideline, patients on GLP-1 still have residual gastric content which increases their risk of aspiration during anesthesia. We aim to investigate the prevalence of full stomachs following different fasting times.

Conditions

Pre-op Gastric Emptying

Study ID

NCT06814080

Start date

May 22, 2025

Status verified date

Sep, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

Age ≥ 18 yr. ASA physical status I- III Elective surgery

Exclusion Criteria:

  • Pregnancy
  • History of upper gastrointestinal disease or previous surgery on the esophagus, stomach or upper abdomen;
  • Documented abnormalities of the upper gastrointestinal tract such as gastric tumors; recent upper gastrointestinal bleeding (within the preceding 1 month).
  • Medicines that may delay gastric emptying (e.g., anticholinergic agents, opioid)
  • ASA class IV or above
  • Unable to understand English
  • Cardiac cases with low ejection fraction
  • Elderly patients above 65 years of age
  • Liver or renal transplant cases
  • Type 1 diabetes Patients on insulin or sulphonylurea medication

Study Design

Enrollment

45 participants

Anticipated

Interventions and Outcome Measures

Arms

8 hour fasting

A standardized gastric scanning protocol will be used, and patients classified following a 3-point grading system based solely on qualitative sonographic assessment of the antrum in the supine and right lateral decubitus positions. A qualitative assessment of the residual gastric fluid volume will be performed, according to the three-point grading scale previously described by Perlas et al. Grade 0 was defined by the absence of visualization of any content into a flat antrum in both the supine and the right lateral decubitus positions. Grade 1 was defined by the appearance of fluid content in the right lateral decubitus position only, and Grade 2 was defined by the visualization of fluid content in both the supine and the right lateral decubitus positions.

10 hour fasting

A standardized gastric scanning protocol will be used, and patients classified following a 3-point grading system based solely on qualitative sonographic assessment of the antrum in the supine and right lateral decubitus positions. A qualitative assessment of the residual gastric fluid volume will be performed, according to the three-point grading scale previously described by Perlas et al. Grade 0 was defined by the absence of visualization of any content into a flat antrum in both the supine and the right lateral decubitus positions. Grade 1 was defined by the appearance of fluid content in the right lateral decubitus position only, and Grade 2 was defined by the visualization of fluid content in both the supine and the right lateral decubitus positions.

12 hour fasting

A standardized gastric scanning protocol will be used, and patients classified following a 3-point grading system based solely on qualitative sonographic assessment of the antrum in the supine and right lateral decubitus positions. A qualitative assessment of the residual gastric fluid volume will be performed, according to the three-point grading scale previously described by Perlas et al. Grade 0 was defined by the absence of visualization of any content into a flat antrum in both the supine and the right lateral decubitus positions. Grade 1 was defined by the appearance of fluid content in the right lateral decubitus position only, and Grade 2 was defined by the visualization of fluid content in both the supine and the right lateral decubitus positions.

Primary outcome measure

  • Prevalence of full stomach or residual gastric content in the 3 groups [ Time Frame: 8 hours ]
  • Prevalence of full stomach or residual gastric content in the 3 groups [ Time Frame: 10 hours ]
  • Prevalence of full stomach or residual gastric content in the 3 groups [ Time Frame: 12 hours ]

Central Contacts and Locations

Central contacts

Mohamed A Abdeldayem, MD

MAAbdeldayem@uams.edu

Locations

University of Arkansas for Medical Science

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Mohamed Abdeldayem, MD

MAAbdeldayem@uams.edu

More Information

Sponsor

University of Arkansas

Last update posted

Sep 18, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arkansas on 2025-09-18.