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GLP-1 RA Cessation and Gastric Ultrasound Findings

28. mai 2026 oppdatert av: Cheol Lee,MD,PhD,, Wonkwang University Hospital

Time-dependent Association Between Cessation of Glucagon-like Peptide-1 Receptor Agonists and Residual Gastric Contents Assessed by Point-of-care Gastric Ultrasound: a Prospective Observational Study

This prospective observational study will evaluate the association between the time interval since the last dose of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and residual gastric contents before elective surgery. Adult patients receiving GLP-1 RAs and scheduled for elective non-cardiac surgery under general anesthesia will undergo preoperative point-of-care gastric ultrasound. The study will assess whether longer GLP-1 RA cessation intervals are associated with lower ultrasound-estimated gastric volume and a lower frequency of high-risk gastric contents. Body mass index will also be evaluated as a potential modifier of this association.

Studieoversikt

Status

Fullført

Intervensjon / Behandling

Detaljert beskrivelse

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are increasingly used for the treatment of type 2 diabetes and obesity. These agents can delay gastric emptying, raising concerns about residual gastric contents and potential aspiration risk during anesthesia. Current perioperative recommendations regarding GLP-1 RA discontinuation are largely consensus-based, and the physiological relationship between cessation interval and residual gastric content remains insufficiently defined.

This single-center prospective observational cohort study will enroll adult patients who are receiving GLP-1 RAs and are scheduled for elective non-cardiac surgery requiring general anesthesia. GLP-1 RA management will follow usual clinical care; the study team will not assign, modify, or instruct the timing of drug discontinuation. The primary exposure will be the number of days since the last GLP-1 RA dose, analyzed both as a continuous variable and according to prespecified cessation-interval categories.

Immediately before induction of anesthesia, participants will undergo standardized point-of-care gastric ultrasound. Qualitative gastric content will be assessed using the Perlas grading system, and quantitative gastric volume will be estimated from the antral cross-sectional area measured in the right lateral decubitus position. The primary outcome will be estimated gastric volume normalized to body weight. Secondary outcomes will include antral cross-sectional area, Perlas grade, and the presence of high-risk gastric contents.

Multivariable regression models will be used to evaluate the association between GLP-1 RA cessation interval and gastric ultrasound findings after adjustment for clinically relevant covariates, including age, sex, body mass index, diabetes status, preoperative fasting duration, and gastrointestinal symptom score. Body mass index will be evaluated as a prespecified effect modifier.

Studietype

Observasjonsmessig

Registrering (Faktiske)

186

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Jeonbuk-do
      • Iksan, Jeonbuk-do, Sør -Korea, 54538
        • Wonkwang University School of Medicine Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

N/A

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Adult patients receiving glucagon-like peptide-1 receptor agonists who are scheduled for elective non-cardiac surgery requiring general anesthesia at a tertiary academic hospital. Participants will be screened consecutively by the perioperative anesthesia team and enrolled if eligibility criteria are met.

Beskrivelse

Inclusion Criteria:

  • Adults aged 18 years or older.
  • Patients receiving a glucagon-like peptide-1 receptor agonist.
  • Patients scheduled for elective non-cardiac surgery requiring general anesthesia.
  • Patients able to provide written informed consent.

Exclusion Criteria:

  • Emergency surgery.
  • History of prior gastric surgery.
  • Known gastroparesis or severe gastroesophageal reflux disease.
  • Declined or unable to provide written informed consent.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Last GLP-1 RA Dose 3 Days or Less
Participants receiving glucagon-like peptide-1 receptor agonists whose last dose was taken 3 days or less before elective surgery. No intervention was assigned by the study protocol; GLP-1 RA management followed usual clinical care. Participants underwent preoperative point-of-care gastric ultrasound to assess residual gastric contents.
Observed exposure defined as the number of days between the participant's last glucagon-like peptide-1 receptor agonist dose and elective surgery. Participants were categorized according to time since last dose: 3 days or less, 4 to 7 days, and 8 days or more. No GLP-1 receptor agonist was assigned, administered, continued, or discontinued by the study protocol; medication management followed usual clinical care.
Andre navn:
  • Time Since Last GLP-1 RA Dose
  • GLP-1 RA Discontinuation Interval
Last GLP-1 RA Dose 4 to 7 Days
Participants receiving glucagon-like peptide-1 receptor agonists whose last dose was taken 4 to 7 days before elective surgery. No intervention was assigned by the study protocol; GLP-1 RA management followed usual clinical care. Participants underwent preoperative point-of-care gastric ultrasound to assess residual gastric contents.
Observed exposure defined as the number of days between the participant's last glucagon-like peptide-1 receptor agonist dose and elective surgery. Participants were categorized according to time since last dose: 3 days or less, 4 to 7 days, and 8 days or more. No GLP-1 receptor agonist was assigned, administered, continued, or discontinued by the study protocol; medication management followed usual clinical care.
Andre navn:
  • Time Since Last GLP-1 RA Dose
  • GLP-1 RA Discontinuation Interval
Last GLP-1 RA Dose 8 Days or More
Participants receiving glucagon-like peptide-1 receptor agonists whose last dose was taken 8 days or more before elective surgery. No intervention was assigned by the study protocol; GLP-1 RA management followed usual clinical care. Participants underwent preoperative point-of-care gastric ultrasound to assess residual gastric contents.
Observed exposure defined as the number of days between the participant's last glucagon-like peptide-1 receptor agonist dose and elective surgery. Participants were categorized according to time since last dose: 3 days or less, 4 to 7 days, and 8 days or more. No GLP-1 receptor agonist was assigned, administered, continued, or discontinued by the study protocol; medication management followed usual clinical care.
Andre navn:
  • Time Since Last GLP-1 RA Dose
  • GLP-1 RA Discontinuation Interval

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Estimated Gastric Volume Normalized to Body Weight
Tidsramme: Immediately before induction of anesthesia on the day of surgery
Estimated gastric volume normalized to body weight, expressed as mL/kg, calculated from the antral cross-sectional area measured by preoperative point-of-care gastric ultrasound in the right lateral decubitus position.
Immediately before induction of anesthesia on the day of surgery

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Antral Cross-Sectional Area
Tidsramme: Immediately before induction of anesthesia on the day of surgery
Antral cross-sectional area measured by preoperative point-of-care gastric ultrasound in the right lateral decubitus position and expressed in cm2.
Immediately before induction of anesthesia on the day of surgery
Perlas Gastric Ultrasound Grade
Tidsramme: Immediately before induction of anesthesia on the day of surgery
Qualitative gastric content assessed using the Perlas grading system. Grade 0 indicates an empty stomach, Grade 1 indicates fluid visible only in the right lateral decubitus position, and Grade 2 indicates fluid visible in both supine and right lateral decubitus positions.
Immediately before induction of anesthesia on the day of surgery
Gastrointestinal Symptom Score
Tidsramme: Within 24 hours before surgery
Preoperative gastrointestinal symptom score assessing nausea, vomiting, bloating, early satiety, and abdominal discomfort.
Within 24 hours before surgery

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studieleder: Cheol Lee, M.D.,Ph.D, Wonkwang University Hosptial

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. februar 2026

Primær fullføring (Faktiske)

27. mars 2026

Studiet fullført (Faktiske)

20. mai 2026

Datoer for studieregistrering

Først innsendt

28. mai 2026

Først innsendt som oppfylte QC-kriteriene

28. mai 2026

Først lagt ut (Faktiske)

3. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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