Ultrasound Measure of Gastric Volume in Diabetic and Non Diabetic Patients Before General Anesthesia

Hopital Foch245 enrolled

Overview

The main objective is to compare the frequency of a " full stomach " in diabetic patients compared with a control population, all the patients having followed the instructions of preoperative fast.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

245

Conditions

Diabetes

Interventions

Ultrasonic measurement of antral areaPROCEDURE

Antral area is measured by ultrasound using a curvilinear abdominal probe of 2-5 MHz and a Logiq E (General Electrics) type echograph or equivalent. Ultrasound is done before the induction of general anesthesia. Three consecutive measurements of the anteroposterior (AP) and cranio-caudal (CC) diameters are performed. Antral area (CSA expressed in mm²) is show by the following formula: CSA = AP × CC × π / 4. Antral area will correspond to the average of the three measures.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged over 18 * American Society of Anesthesiologists (ASA) classification 1 to 3 * Needed a general anesthesia for a programmed surgical intervention * Respect of instructions of the pre-operative fasting; * Affiliation to the social security; * Consent form signed Non inclusion Criteria: * Pregnant or breastfeeding women * Patients already operated or to be operated from the upper digestive tract (esophagus, stomach, duodenum) * Patients treated with a prokinetic treatment and / or a level 3 analgesic Exclusion criteria * Unfeasibility to ultrasound measurement of antral area * Failure to observe fasting instructions

Locations (3)

Fondation Ophtalmologique Adolphe de Rotschild

Paris, France

AP-HP Hopital Tenon

Paris, France

Hopital Foch

Suresnes, France

Outcomes

Primary Outcomes

Number of patients with full stomach

The main objective is to compare the frequency of a "full stomach" in the diabetic population compared to a "control" population just before induction of general anesthesia. A "full stomach" is defined by an antral area \> 340 mm2 The main objective is to compare the frequency of a "full stomach" in the diabetic population compared to a "control" population just before induction of general anesthesia. A "full stomach" is defined by an antral area \> 340 mm2

Time frame: one day

Secondary Outcomes

Glycemia

To assess the relationship between preoperative blood glucose and gastric emptying in the diabetic population

Time frame: one day

Fast duration

To compare the impact of the duration of fasting on the gastric residue in both populations of patients (diabetic and non-diabetic)

Time frame: one day

Glycated hemoglobin

To assess the relationship between glycated hemoglobin and gastric emptying in the diabetic population

Time frame: one day

Evaluation of anxiety using a numerical scale (from 0 -no anxiety- to 10 -maximal anxiety-)

To compare the impact of anxiety on the gastric residue in both populations of patients (diabetic and non-diabetic) in both populations of patients (diabetic and non-diabetic)

Time frame: one day

Evaluation of anxiety using a numerical scale (from 0 -no pain- to 10 -maximal pain-)

To compare the impact of pain on the gastric residue in both populations of patients (diabetic and non-diabetic) in both populations of patients (diabetic and non-diabetic)

Data from ClinicalTrials.gov

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