Role of Gastric Ultrasound in Preoperative Assessment of Gastric Volume in Diabetic Patients.
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|ClinicalTrials.gov Identifier: NCT03438305|
Recruitment Status : Not yet recruiting
First Posted : February 19, 2018
Last Update Posted : February 19, 2018
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.
|Condition or disease||Intervention/treatment|
|Gastroparesis||Other: sonar assessment of gastric volume in Diabetic patients Other: sonar assessment of gastric volume in Non Diabetic patients|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||48 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Role of Gastric Ultrasound in Preoperative Assessment of Gastric Volume in Longstanding Diabetic Patients. (Prospective Observational Study).|
|Estimated Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||June 1, 2018|
|Estimated Study Completion Date :||June 1, 2018|
Other: sonar assessment of gastric volume in Diabetic patients
assessment of gastric volume in Diabetic Patients
Other: sonar assessment of gastric volume in Non Diabetic patients
assessment of gastric volume in Non- Diabetic Patients
- assessment of residual gastric volume in longstanding diabetic patients [ Time Frame: intra-operative ]To assess the residual gastric volume in longstanding diabetic patients compared to non diabetic patients
- correlation between preoperative gastric US findings and fasting hours in both groups [ Time Frame: intraoperative ]To correlate between preoperative gastric US findings and fasting hours in both groups to confirm delayed gastric emptying in diabetic group.