Diabetes
Conditions
Keywords
Gastric contents, Ultrasound, Diabetes
Brief summary
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.
Interventions
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.
Sponsors
Hopital Foch
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with full stomach | one day | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fast duration | one day | To compare the impact of the duration of fasting on the gastric residue in both populations of patients (diabetic and non-diabetic) |
| Glycated hemoglobin | one day | To assess the relationship between glycated hemoglobin and gastric emptying in the diabetic population |
| Glycemia | one day | To assess the relationship between preoperative blood glucose and gastric emptying in the diabetic population |
| Evaluation of anxiety using a numerical scale (from 0 -no pain- to 10 -maximal pain-) | one day | 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) |
| Intraoperative hypoxemia | one day | Evaluation of the risk of intraoperative pulmonary inhalation in both populations of patients (diabetic and non-diabetic) |
| Evaluation of anxiety using a numerical scale (from 0 -no anxiety- to 10 -maximal anxiety-) | one day | 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) |
Countries
France
Outcome results
None listed