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

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Procedure: Ultrasonic measurement of antral area

• Registration Number: NCT03036774
• Lead Sponsor: Hopital Foch

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-27
• Study First Submitted QC: 2017-01-27
• Study First Posted: 2017-01-30
• Study Start: 2017-02-14
• Primary Completion: 2019-02-06
• Study Completion: 2019-02-06
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-13
• Last Update Posted: 2020-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non diabetic patient	Ultrasonic measurement of antral area	Patients with scheduled surgery without history of diabetes or a current, treated or untreated, diabetic disease. Ultrasonic measurement of antral area
Diabetic patient	Ultrasonic measurement of antral area	Diabetic patients (type 1 or type 2 diabetes) with scheduled surgery . Ultrasonic measurement of antral area

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Glycated hemoglobin	one day	To assess the relationship between glycated hemoglobin and gastric emptying in the diabetic population
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)
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 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)
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)

Trial Locations

Locations (3)

Fondation Ophtalmologique Adolphe de Rotschild; 🇫🇷 Paris, France

AP-HP Hopital Tenon; 🇫🇷 Paris, France

Hopital Foch; 🇫🇷 Suresnes, France