Pre-op Gastric EmptyingNCT06814080
Residual Gastric Content and GLP-1
An observational study of Pre-op Gastric Emptying, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pre-op Gastric Emptying
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2025to 1 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age ≥ 18 yr. ASA physical status I- III Elective surgery
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Science
Little Rock, Arkansas, 72205
About this study
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.
Read the 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
- Conditions
- Pre-op Gastric Emptying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of full stomach or residual gastric content in the 3 groups
Empty stomach when no content or clear liquids are visibly inferior to 1.5ml/kg. Full stomach includes the visualization of solids on gastric ultrasonography or a volume of clear liquids greater than 1.5ml/kg.
Measured: 8 hours
Prevalence of full stomach or residual gastric content in the 3 groups
Empty stomach when no content or clear liquids are visibly inferior to 1.5ml/kg. Full stomach includes the visualization of solids on gastric ultrasonography or a volume of clear liquids greater than 1.5ml/kg.
Measured: 10 hours
Prevalence of full stomach or residual gastric content in the 3 groups
Empty stomach when no content or clear liquids are visibly inferior to 1.5ml/kg. Full stomach includes the visualization of solids on gastric ultrasonography or a volume of clear liquids greater than 1.5ml/kg.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start22 May 2025
- Primary completion1 Aug 2026
- Study completion1 Aug 2026
Why it stopped: The study was Terminated by primary investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-op Gastric EmptyingStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814080
- Sponsor's protocol ID
- 287139
- Status last verified
- Oct 2026
- First submitted
- 3 Feb 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Residual Gastric Content and GLP-1
- ClinicalTrials.gov ID
- NCT06814080
- Acronym / sponsor ID
- 287139
- Conditions
- Pre-op Gastric Emptying
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was Terminated by primary investigator
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 22 May 2025 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Age ≥ 18 yr. ASA physical status I- III Elective surgery
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of full stomach or residual gastric content in the 3 groups
Time frame: 8 hours
Empty stomach when no content or clear liquids are visibly inferior to 1.5ml/kg. Full stomach includes the visualization of solids on gastric ultrasonography or a volume of clear liquids greater than 1.5ml/kg.
Prevalence of full stomach or residual gastric content in the 3 groups
Time frame: 10 hours
Empty stomach when no content or clear liquids are visibly inferior to 1.5ml/kg. Full stomach includes the visualization of solids on gastric ultrasonography or a volume of clear liquids greater than 1.5ml/kg.
Prevalence of full stomach or residual gastric content in the 3 groups
Time frame: 12 hours
Empty stomach when no content or clear liquids are visibly inferior to 1.5ml/kg. Full stomach includes the visualization of solids on gastric ultrasonography or a volume of clear liquids greater than 1.5ml/kg.
Results and safety
The study was stopped early (reason given: The study was Terminated by primary investigator). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-op Gastric Emptying, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was Terminated by primary investigator). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of full stomach or residual gastric content in the 3 groups (time frame: 8 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.