Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

GLP-1 RA Cessation and Gastric Ultrasound Findings

28 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

186

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Jeonbuk-do
      • Iksan, Jeonbuk-do, Corea del Sud, 54538
        • Wonkwang University School of Medicine Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

N/A

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Altri nomi:
  • 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.
Altri nomi:
  • 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.
Altri nomi:
  • Time Since Last GLP-1 RA Dose
  • GLP-1 RA Discontinuation Interval

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Estimated Gastric Volume Normalized to Body Weight
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Antral Cross-Sectional Area
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Within 24 hours before surgery
Preoperative gastrointestinal symptom score assessing nausea, vomiting, bloating, early satiety, and abdominal discomfort.
Within 24 hours before surgery

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Direttore dello studio: Cheol Lee, M.D.,Ph.D, Wonkwang University Hosptial

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

4 febbraio 2026

Completamento primario (Effettivo)

27 marzo 2026

Completamento dello studio (Effettivo)

20 maggio 2026

Date di iscrizione allo studio

Primo inviato

28 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 maggio 2026

Primo Inserito (Effettivo)

3 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

3 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Svuotamento gastrico ritardato

Prove cliniche su GLP-1 RA Cessation Interval

Sottoscrivi