Clinical trial NCT06814080: Residual Gastric Content and GLP-1
Official title: Residual Gastric Content and GLP-1
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pre-op Gastric Emptying
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects on GLP-1 scheduled for elective surgery will be screened for recruitment. We will find prospective subjects via medical records review or through our preoperative evaluation team which is a standard of care and then contact the patients about the study. Subjects enrolled in the study will be treated as per normal practice for elective surgery.

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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of full stomach or residual gastric content in the 3 groups
timeFrame: 8 hours
measure: Prevalence of full stomach or residual gastric content in the 3 groups
timeFrame: 10 hours
measure: Prevalence of full stomach or residual gastric content in the 3 groups
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Science
state: Arkansas
Study officials:
References: