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临床试验/NCT07519447
NCT07519447已完成不适用

Ultrasonographic Assessment of Preoperative Gastric Residual Volume and Aspiration Risk Following Intravenous Metoclopramide in Fasted Diabetic Patients Undergoing Elective Surgery Under General Anesthesia: A Prospective Non-Randomized Controlled Comparative Study

Kafrelsheikh University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Antral cross-sectional area

研究概览

简要总结

This study aimed to evaluate the effect of metoclopramide on preoperative gastric emptying in diabetic patients.

详细描述

Perioperative aspiration of gastric contents is a rare but serious complication of anesthesia. Aspiration pneumonia is associated with significant morbidity, including prolonged mechanical ventilation, and carries a risk of mortality as great as 5%.

Point-of-care (POC) gastric ultrasound has gained popularity in recent times. It has been adapted in the field of anesthesiology gradually to make the clinical decision before anesthetizing patients where the fasting status is uncertain and in emergency patients where surgery is mandated.

Metoclopramide, a medication used for diabetic gastroparesis, is a cholinergic agent that acts by increasing the release of acetylcholine at the neuromuscular junction within the gastric wall. Further, metoclopramide has antidopaminergic properties that inhibit dopamine-induced gastric smooth muscle relaxation, and it also penetrates the blood-brain barrier and binds to medullary chemoreceptors.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age from 18 to 65 years old.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status I-II.
  • Underwent elective surgery.

排除标准

  • Patients taking drugs that affect gastric motility.
  • Patients with renal failure.
  • Hypothyroidism.
  • Obesity [body mass index (BMI) > 30kg/m2].
  • Connective tissue disorders.
  • History of gastrointestinal surgery.
  • Those with steroid-induced hyperglycemia.
  • Pregnancy.

研究组 & 干预措施

Group II

Diabetic patients who did not receive metoclopramide or any other prokinetic agent preoperatively.

Group III

Non-diabetic patients who did not receive metoclopramide, serving as a healthy reference group.

Group I

Diabetic patients received a single IV dose of metoclopramide 10 mg (2 mL) administered 30-60 minutes prior to POC gastric ultrasound assessment, to allow for peak prokinetic effect.

干预措施: Metoclopramide (Drug)

结局指标

主要结局

Antral cross-sectional area

时间窗: 30 minutes after drug administration

Antral cross-sectional area (CSA) was measured by Point-of-Care (POC) ultrasound (cm²). Antral CSA was calculated using the standard ellipse formula: Antral CSA (cm²) = π/4 × antero-posterior (AP) (cm) × cranio-caudal (CC) (cm)

次要结局

  • Gastric volume(30 minutes after drug administration)
  • Antral gastric grade(30 minutes after drug administration)
  • Fasting glucose(30 minutes after drug administration)

研究者

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

Mahmoud Fawzy Elsharkawy

Lecturer of Anesthesia, Surgical Intensive Care and Pain Management, Faculty of Medicine, Kafr Elsheikh University, Kafr Elsheikh, Egypt.

Kafrelsheikh University

研究点 (1)

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