Evaluation of the Effect of Hemoglobin A1c Levels on Gastric Emptying Assessed by Gastric Ultrasound
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Gastric emptying assessed by gastric ultrasound
研究概览
简要总结
Delayed gastric emptying increases the risk of pulmonary aspiration during general anesthesia. Diabetes mellitus and poor long-term glycemic control have been associated with impaired gastric motility. Hemoglobin A1c (HbA1c) is a marker of long-term glycemic control; however, its relationship with gastric emptying in surgical patients is not fully understood.
This prospective observational study aims to evaluate the association between HbA1c levels and gastric emptying using preoperative bedside gastric ultrasonography. Adult patients scheduled for elective surgery under general anesthesia will undergo gastric ultrasound examination after standard fasting. Gastric antral cross-sectional area and estimated gastric volume will be assessed and compared according to HbA1c levels.
The findings of this study may help improve preoperative risk stratification for aspiration and support individualized anesthetic management in patients with impaired glycemic control.
详细描述
This prospective observational study is designed to evaluate the relationship between hemoglobin A1c (HbA1c) levels and gastric emptying in adult surgical patients using bedside gastric ultrasonography.
Adult patients aged 18 to 70 years, scheduled for elective surgery under general anesthesia, will be enrolled. After standard preoperative fasting according to current guidelines, all participants will undergo a preoperative gastric ultrasound examination performed by a trained anesthesiologist. The gastric antrum will be assessed in standardized positions, and the antral cross-sectional area will be measured. Estimated gastric volume will be calculated using validated ultrasound-based formulas.
HbA1c levels will be obtained from preoperative laboratory records, and patients will be analyzed according to their HbA1c values. Gastric ultrasound findings, including antral cross-sectional area and estimated gastric volume, will be compared across different HbA1c levels.
Demographic data, anthropometric measurements including body mass index and waist circumference, fasting duration, and relevant clinical characteristics will also be recorded. The primary objective is to assess the association between HbA1c levels and gastric emptying parameters. Secondary analyses will explore potential factors associated with delayed gastric emptying.
The results of this study may contribute to improved preoperative risk assessment for pulmonary aspiration and support individualized anesthetic management in patients with impaired glycemic control.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 70 years. ASA physical status I-III. Scheduled for elective surgery under general anesthesia. Ability to provide written informed consent.
排除标准
- •Scheduled for emergency surgery. Refusal or inability to provide informed consent. Pregnancy. Age <18 years or >70 years. History of gastric surgery. Neuromuscular disease. Current use of opioid or anticholinergic medications.
研究组 & 干预措施
Study Population
Adult patients scheduled for elective surgery under general anesthesia who undergo preoperative bedside gastric ultrasonography as part of an observational study.
结局指标
主要结局
Gastric emptying assessed by gastric ultrasound
时间窗: The preoperative period,immediately before induction of anesthesia
Gastric emptying will be assessed preoperatively using bedside gastric ultrasonography by measuring gastric antrum cross-sectional area and estimating gastric volume with validated ultrasound-based methods.
次要结局
未报告次要终点
研究者
Merve Yaman
MD,Assistant Professor of Anesthesiology
Kutahya Health Sciences University