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- Ensaio 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
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Jeonbuk-do
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Iksan, Jeonbuk-do, Coréia do Sul, 54538
- Wonkwang University School of Medicine Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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.
Outros nomes:
|
|
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.
Outros nomes:
|
|
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.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Estimated Gastric Volume Normalized to Body Weight
Prazo: Immediately before induction of anesthesia on the day of surgery
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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.
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Immediately before induction of anesthesia on the day of surgery
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Antral Cross-Sectional Area
Prazo: Immediately before induction of anesthesia on the day of surgery
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Antral cross-sectional area measured by preoperative point-of-care gastric ultrasound in the right lateral decubitus position and expressed in cm2.
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Immediately before induction of anesthesia on the day of surgery
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Perlas Gastric Ultrasound Grade
Prazo: Immediately before induction of anesthesia on the day of surgery
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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.
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Immediately before induction of anesthesia on the day of surgery
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Gastrointestinal Symptom Score
Prazo: Within 24 hours before surgery
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Preoperative gastrointestinal symptom score assessing nausea, vomiting, bloating, early satiety, and abdominal discomfort.
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Within 24 hours before surgery
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Cheol Lee, M.D.,Ph.D, Wonkwang University Hosptial
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Wonkwang UH25
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