Clinical trial NCT03438305: Role of Gastric Ultrasound in Preoperative Assessment of Gastric Volume in Diabetic Patients.
Official title: Role of Gastric Ultrasound in Preoperative Assessment of Gastric Volume in Longstanding Diabetic Patients. (Prospective Observational Study).
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastroparesis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Diabetic patients with long standing diabetis ( more than 6 years) so , it may affect gastric nerve supply.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: assessment of residual gastric volume in longstanding diabetic patients
timeFrame: intra-operative
Secondary outcomes:
measure: correlation between preoperative gastric US findings and fasting hours in both groups
timeFrame: intraoperative
Other outcomes:
Locations:
Study officials:
References:
citation: Sabry R, Hasanin A, Refaat S, Abdel Raouf S, Abdallah AS, Helmy N. Evaluation of gastric residual volume in fasting diabetic patients using gastric ultrasound. Acta Anaesthesiol Scand. 2019 May;63(5):615-619. doi: 10.1111/aas.13315. Epub 2019 Jan 4.