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临床试验/NCT07360262
NCT07360262已完成不适用

Time-dependent Recovery of Gastric Emptying After Cessation of Glucagon-like Peptide-1 Receptor Agonists: a Prospective Observational Gastric Ultrasound Study

Wonkwang University Hospital2 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2025年11月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
186
试验地点
2
主要终点
Ultrasound-estimated gastric volume (mL/kg)

研究概览

简要总结

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) can delay gastric emptying and may increase residual gastric contents before general anesthesia. Current perioperative recommendations for withholding GLP-1 RAs (e.g., a fixed 7-day discontinuation for weekly agents) are largely consensus-based, and it is unclear whether gastric emptying normalizes abruptly after a single threshold interval. This prospective observational cohort study will evaluate how preoperative residual gastric content changes with increasing time since the last GLP-1 RA dose, using point-of-care gastric ultrasound performed immediately before induction of anesthesia. Time since last dose will be analyzed as a continuous exposure and across prespecified intervals (≤3 days, 4-7 days, ≥8 days). The primary outcome is ultrasound-estimated gastric volume normalized to body weight (mL/kg), derived from antral cross-sectional area. Secondary outcomes include the presence of a "high-risk stomach" based on gastric volume criteria and qualitative ultrasound findings. The study will also assess whether body mass index modifies the relationship between cessation interval and gastric volume, thereby supporting individualized perioperative risk assessment.

详细描述

Study design and setting: This is a prospective observational cohort study conducted at a tertiary academic hospital to evaluate gastric emptying recovery after cessation of GLP-1 receptor agonists. Adult patients (≥18 years) receiving GLP-1 RAs and scheduled for elective surgery under general anesthesia will be enrolled consecutively to minimize selection bias. Prespecified exclusions include prior gastric or esophageal surgery, known gastroparesis, severe gastroesophageal reflux disease, emergency surgery, pregnancy, and inability to provide informed consent.

Exposure (no intervention assignment): The study does not assign or modify GLP-1 RA therapy. Time since the last GLP-1 RA dose will be recorded in days using patient report and medical records and analyzed both as a continuous variable and as prespecified categories (≤3 days, 4-7 days, ≥8 days). Information on GLP-1 RA formulation (weekly vs daily) and dose equivalence may be collected for sensitivity analyses. Potential confounders such as fasting duration and type of surgery will be recorded.

Gastric ultrasound procedures: Point-of-care gastric ultrasound will be performed immediately before induction of anesthesia using a standardized protocol by trained consultant anesthesiologists. The gastric antrum will be assessed in the supine and right lateral decubitus positions. Qualitative assessment of gastric content will be documented, and quantitative measurements of antral cross-sectional area will be used to estimate gastric volume.

Outcomes: The primary outcome is estimated gastric volume normalized to body weight (mL/kg). Secondary outcomes include the presence of a high-risk stomach, as defined by prespecified gastric volume criteria and qualitative ultrasound findings. Additional exploratory analyses will evaluate whether body mass index modifies the association between cessation interval and gastric volume and whether patient-reported gastrointestinal symptoms correlate with ultrasound findings.

Analysis overview: Associations between time since the last GLP-1 RA dose and gastric ultrasound outcomes will be assessed using prespecified regression models adjusted for relevant covariates (e.g., age, sex, BMI, diabetes status, fasting duration, and symptom measures). The interaction between BMI and cessation interval will be evaluated to characterize potential effect modification.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged ≥18 years
  • Receiving a glucagon-like peptide-1 receptor agonist (GLP-1 RA)
  • Scheduled for elective surgery under general anesthesia
  • Able to provide written informed consent

排除标准

  • Prior gastric or esophageal surgery
  • Known gastroparesis
  • Severe gastroesophageal reflux disease
  • Emergency surgery
  • Pregnancy
  • Inability to provide informed consent

研究组 & 干预措施

GLP-1 RA cessation ≤3 days

Participants using GLP-1 receptor agonists whose last dose was taken ≤3 days before the preoperative gastric ultrasound assessment (performed immediately prior to induction of anesthesia).

干预措施: Preoperative gastric ultrasound (Other)

GLP-1 RA cessation 4-7 days

Participants using GLP-1 receptor agonists whose last dose was taken 4-7 days before the preoperative gastric ultrasound assessment (performed immediately prior to induction of anesthesia).

干预措施: Preoperative gastric ultrasound (Other)

GLP-1 RA cessation ≥8 days

Participants using GLP-1 receptor agonists whose last dose was taken ≥8 days before the preoperative gastric ultrasound assessment (performed immediately prior to induction of anesthesia).

干预措施: Preoperative gastric ultrasound (Other)

结局指标

主要结局

Ultrasound-estimated gastric volume (mL/kg)

时间窗: Immediately preoperatively (just before induction of anesthesia)

Estimated gastric volume normalized to body weight (mL/kg) was calculated from the gastric antral cross-sectional area measured by preoperative point-of-care ultrasound using validated equations.

次要结局

  • Perlas grade of gastric content (0-2)(Immediately preoperatively (just before induction of anesthesia))
  • Antral cross-sectional area (CSA, cm²)(Immediately preoperatively (just before induction of anesthesia))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cheol Lee,MD,PhD,

Professor

Wonkwang University Hospital

研究点 (2)

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