- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07623148
GLP-1 RA Cessation and Gastric Ultrasound Findings
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
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Jeonbuk-do
-
Iksan, Jeonbuk-do, Etelä -Korea, 54538
- Wonkwang University School of Medicine Hospital
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
|
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.
Muut nimet:
|
|
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.
Muut nimet:
|
|
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.
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Estimated Gastric Volume Normalized to Body Weight
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Antral Cross-Sectional Area
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Within 24 hours before surgery
|
Preoperative gastrointestinal symptom score assessing nausea, vomiting, bloating, early satiety, and abdominal discomfort.
|
Within 24 hours before surgery
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: Cheol Lee, M.D.,Ph.D, Wonkwang University Hosptial
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- Wonkwang UH25
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
Kliiniset tutkimukset Viivästynyt mahalaukun tyhjennys
-
Second Affiliated Hospital, School of Medicine,...ValmisFundal Gastric Varices | Endoskooppisen ultraäänen (EUS) ohjaama kierrutus | Titaaniklipit | Ektopinen embolisointi | MahalaskimopaineKiina
Kliiniset tutkimukset GLP-1 RA Cessation Interval
-
The University of Texas Health Science Center,...Rekrytointi
-
University of MinnesotaCystic Fibrosis FoundationValmis
-
Moscow Regional Research and Clinical Institute...Botkin Hospital; Sechenov UniversityValmisTyypin 2 diabetes (T2DM) | Metabolinen toimintahäiriöön liittyvä rasvamaksatauti (MAFLD)Venäjä
-
University of South CarolinaPrisma Health-UpstateRekrytointiLiikalihavuus (häiriö) | Liikalihavuus Tyypin 2 diabetes mellitusYhdysvallat
-
Brigham and Women's HospitalNovo Nordisk A/S via Research Grant to Brigham and Women's HospitalValmisSydän-ja verisuonitaudit | DiabetesYhdysvallat
-
Boehringer IngelheimValmis
-
Ludwig-Maximilians - University of MunichGerman Research Foundation; Merck Sharp & Dohme LLCValmis
-
Zealand PharmaProfil Institut für Stoffwechselforschung GmbHLopetettuTurvallisuus ja siedettävyysSaksa
-
Zealand PharmaValmis
-
University Hospital, Strasbourg, FranceCentre de Recherche en biomédecine de Strasbourg INSERM UMR-S1118Ei vielä rekrytointiaClaudikaatio, ajoittainen | Perifeerinen valtimotauti (PAD) | Krooninen raajaa uhkaava iskemiaRanska