- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
Jeonbuk-do
-
Iksan, Jeonbuk-do, Zuid -Korea, 54538
- Wonkwang University School of Medicine Hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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.
Andere namen:
|
|
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.
Andere namen:
|
|
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.
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Estimated Gastric Volume Normalized to Body Weight
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Antral Cross-Sectional Area
Tijdsspanne: 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
Tijdsspanne: Immediately before induction of anesthesia on the day of surgery
|
Qualitative gastric content will be assessed using the Perlas Gastric Ultrasound Grading System, which ranges from Grade 0 to Grade 2. 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 the supine and right lateral decubitus positions.
Higher grades indicate greater residual gastric content.
|
Immediately before induction of anesthesia on the day of surgery
|
|
Gastrointestinal Symptom Score
Tijdsspanne: Within 24 hours before surgery
|
Preoperative gastrointestinal symptoms will be assessed using a Gastrointestinal Symptom Numeric Rating Scale for nausea, vomiting, bloating, early satiety, and abdominal discomfort.
Each symptom is rated from 0 to 10, where 0 indicates no symptom and 10 indicates the worst imaginable symptom.
The total score ranges from 0 to 50, with higher scores indicating more severe gastrointestinal symptoms.
|
Within 24 hours before surgery
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Cheol Lee, M.D.,Ph.D, Wonkwang University Hosptial
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Wonkwang UH25
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Vertraagde maaglediging
-
Cairo UniversityWerving
-
RSP Systems A/SVoltooid
-
State University of New York - Upstate Medical...BeëindigdGastric Bypass-statusVerenigde Staten
-
Mayo ClinicNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)IngetrokkenGastric Bypass-operatie
-
Medtronic - MITGVoltooid
-
Olympus Corporation of the AmericasUnity Health TorontoVoltooid
-
Jessa HospitalNog niet aan het werven
-
North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaVoltooidRoux en Y Gastric BypassVerenigde Staten
-
North Dakota State UniversityNational Institutes of Health (NIH)VoltooidRoux en Y Gastric Bypass ChirurgieVerenigde Staten
-
North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaVoltooidSleeve gastrectomie | Roux en Y Gastric BypassVerenigde Staten
Klinische onderzoeken op GLP-1 RA Cessation Interval
-
Emory UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Nog niet aan het wervenDiabetes mellitus, type 2Verenigde Staten
-
The University of Texas Health Science Center,...Werving
-
University of MinnesotaCystic Fibrosis FoundationVoltooid
-
University of South CarolinaPrisma Health-UpstateWervingObesitas (aandoening) | Obesitas Type 2 Diabetes MellitusVerenigde Staten
-
Moscow Regional Research and Clinical Institute...Botkin Hospital; Sechenov UniversityVoltooidDiabetes mellitus type 2 (T2DM) | Metabole disfunctie-geassocieerde leververvetting (MAFLD)Rusland
-
Ludwig-Maximilians - University of MunichGerman Research Foundation; Merck Sharp & Dohme LLCVoltooidHyperglykemieDuitsland
-
Brigham and Women's HospitalNovo Nordisk A/S via Research Grant to Brigham and Women's HospitalVoltooidHart-en vaatziekten | SuikerziekteVerenigde Staten
-
Zealand PharmaProfil Institut für Stoffwechselforschung GmbHBeëindigdVeiligheid en verdraagzaamheidDuitsland
-
Zealand PharmaVoltooid
-
University Hospital, Strasbourg, FranceCentre de Recherche en biomédecine de Strasbourg INSERM UMR-S1118Nog niet aan het wervenClaudicatio, intermitterend | Perifere arteriële ziekte (PAD) | Chronische ledemaatbedreigende ischemieFrankrijk