跳至主要内容
临床试验/NCT03438305
NCT03438305Unknown不适用

Role of Gastric Ultrasound in Preoperative Assessment of Gastric Volume in Longstanding Diabetic Patients. (Prospective Observational Study).

Cairo University0 个研究点目标入组 48 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
48
主要终点
assessment of residual gastric volume in longstanding diabetic patients

研究概览

简要总结

Background :An important risk factor for aspiration is gastric volume, determined in large part by gastric emptying. Unfortunately, measuring gastric volume over time is not easy, and scintigraphy has remained the gold standard technique for many years. Ultrasound has progressively emerged as a useful substitute due to its reduced cost and ease of performance Objectives:Assess whether ultrasonographic measurement of antral cross sectional area (CSA) can be used reliably for the diagnosis of risk stomach which defined by a gastric content volume at risk of clinical consequences for pulmonary aspiration (i.e., presence of solid particles and/or gastric fluid volume >1.5 ml/kg) during the preoperative period in longstanding diabetic patients.

Study population :

  • -Longstanding diabetic patients (group D)
  • -Non diabetic patients (group N) Study Design : Prospective observational study This study will be conducted at Kasr alainy Hospital; Faculty of Medicine, Cairo University.Patients scheduled for elective operations need General Anesthesia (GA) with endotracheal intubation in theatre of general surgery Preoperative ultrasound to assess gastric residual volume then general anesthesia induction will be Modified Rapid-sequence Induction as follow; Group (D)/(N) : propofol 2-3mg/kg and fentanyl 1 µg/Kg followed by Rocuronium 0.6-1.2 mg/kg.

Suction of Gastric Contents by Nasogastric tube (18 french) will be inserted First set of analysis will be comparing preoperative US findings in 2 groups.

Second set of analysis will be finding correlation between US findings and suction volume in two groups.

Outcome parameters: To assess the residual gastric volume in longstanding diabetic patients compared to non diabetic patients.

Sample Size ; was calculated as 48 patients (24) in each group.

研究设计

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

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Ages from 40 to 60 years old.
  • American Society of Anesthiologist (ASA) II.
  • Diabetic patients with longstanding duration(more than 6 years).

排除标准

  • Age <40,>60 years .
  • Pregnant female
  • Obese patients (BMI ≤40)
  • Patients with Gastric Intestinal Tract (GIT) diseases affect gastric emptying.
  • Diabetic patients less than 6 years.

结局指标

主要结局

assessment of residual gastric volume in longstanding diabetic patients

时间窗: intra-operative

To assess the residual gastric volume in longstanding diabetic patients compared to non diabetic patients

次要结局

  • correlation between preoperative gastric US findings and fasting hours in both groups(intraoperative)

研究者

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

Sherin Refaat

Lecturer of Anesthiology

Cairo University

相似试验