- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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 de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Jeonbuk-do
-
Iksan, Jeonbuk-do, Corea del Sur, 54538
- Wonkwang University School of Medicine Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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.
Otros nombres:
|
|
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.
Otros nombres:
|
|
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Estimated Gastric Volume Normalized to Body Weight
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Antral Cross-Sectional Area
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Within 24 hours before surgery
|
Preoperative gastrointestinal symptom score assessing nausea, vomiting, bloating, early satiety, and abdominal discomfort.
|
Within 24 hours before surgery
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Cheol Lee, M.D.,Ph.D, Wonkwang University Hosptial
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Wonkwang UH25
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre GLP-1 RA Cessation Interval
-
Emory UniversityNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Aún no reclutandoDiabetes Mellitus, Tipo 2Estados Unidos
-
The University of Texas Health Science Center,...Reclutamiento
-
Moscow Regional Research and Clinical Institute...Botkin Hospital; Sechenov UniversityTerminadoDiabetes mellitus tipo 2 (DM2) | Enfermedad hepática grasa asociada a la disfunción metabólica (MAFLD)Rusia
-
University of South CarolinaPrisma Health-UpstateReclutamientoObesidad (Trastorno) | Obesidad Diabetes Mellitus Tipo 2Estados Unidos
-
Ludwig-Maximilians - University of MunichGerman Research Foundation; Merck Sharp & Dohme LLCTerminado
-
Zealand PharmaProfil Institut für Stoffwechselforschung GmbHTerminadoSeguridad y tolerabilidadAlemania
-
Zealand PharmaTerminado
-
University Hospital, Strasbourg, FranceCentre de Recherche en biomédecine de Strasbourg INSERM UMR-S1118Aún no reclutandoClaudicación Intermitente | Enfermedad Arterial Periférica (EAP) | Isquemia crónica que amenaza las extremidadesFrancia
-
Shanghai Chest HospitalThe Second People's Hospital of Anhui Province; The Third Affiliated Hospital... y otros colaboradoresTerminadoDiabetes mellitus tipo 2 (DM2) | Fibrilación auricular (FA)Porcelana
-
Northwestern UniversityGenentech, Inc.ReclutamientoEsclerosis múltipleEstados Unidos