| Registry | NCT06814080 |
|---|---|
| Status | Terminated - The study was Terminated by primary investigator |
| Study type | Observational |
| Enrollment | 15 (Actual) |
| Sponsor | University of Arkansas (Other) |
| Conditions | Pre-op Gastric Emptying |
| Dates | start 2025-05-22, primary completion 2026-08-01, completion 2026-08-01, first posted 2025-02-07, last updated 2026-10-20 |
| Locations | 1 site in United States |
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All trials for Pre-op Gastric Emptying
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.
Glucagon-like peptide-1 (GLP-1) receptor agonists have become increasingly popular as both diabetic and weight loss therapies. One effect of this class of medication is delayed gastric emptying, which may impact the risk of aspiration during anesthesia delivery. Some of them have a very long half-life of approximately one week. Thus, it takes approximately five weeks to achieve its steady-state concentration, and just as long for its effects to terminate after stopping the drug.
As a standard of care, patients are allowed to drink up to 2 hours and to eat up to 8 hours before surgery. Studies have shown that even following the fasting guideline, patients still have residual gastric content which increases their risk of aspiration during anesthesia. Since stopping these drugs for a long time is not practical as it is going to disrupt their glycemic control and reverse the weight loss, we propose to test extending the fasting time.
We aim to investigate the prevalence of full stomachs following different fasting times.
patients will be assigned to one of three groups: Group 1(G1) with 8-hour fasting, Group 2 (G2) with 10-hour fasting, and Group 3 (G3) groups with 12-hour fasting
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 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. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| University of Arkansas for Medical Science | Little Rock, Arkansas | United States |