Safety and Efficacy of Carbohydrate Drink Ingested Two Hours Before Upper Endoscopy Under General Anaesthesia (ENDOGLUcide)

Caen University Hospital

Status: Completed

Conditions: Upper Gastrointestinal Endoscopy

Treatments: Procedure: group drink

Study type: Interventional

Funder types: Other

Identifiers

NCT01471600

08-009

2008-A00255-50

Details and patient eligibility

About

In several national anaesthesia societies, clear fluids are allowed up to 2 hours before general anaesthesia (GA) and light meals up to 6h. Because of aspiration risk, strict fasting remains routine. Recently, surgical studies proved that pre-operative carbohydrate-rich drink reduces preoperative discomfort without affecting gastric fluid volume and acidity.The aim of this study was to show the effects of preanaesthetic oral fluid in patients undergoing upper endoscopy without emergency. The expected efficacy is a reduction of the preoperative discomfort. The investigators thus propose a randomised prospective open-label study to assess efficacy of preanaesthetic oral glucose drink in patients undergoing upper endoscopy without emergency. Study compare two groups : group "drink" (200 ml of fruit juice without pulp ± 200 ml of coffee or tea, 2 at 4 hours before the induction of anaesthesia) and group "overnight fasting".Discomfort was measured at 2 hours before GA (H-2), just before GA (H0) and 4h after anaesthesia (H+4). Each item (anxiety, thirst, hunger, nervousness, tiredness, nausea) was estimated by visual analogue scale (VAS from 0 to 100mm) and handgrip strength by dynamometer. Gastroenterologist assessed the quality of endoscopy (VAS), gastric residual fluid and acidity.The main aim of this study was to assess in patients referred for upper endoscopy under general anaesthesia, the effect of carbohydrate drink on preanaesthetic discomfort. Secondary purpose were to compare quality of endoscopy, residual gastric volumes, gastric acidity and incidence of side effects. 118 patients will be included in the study. A stratification will be made on the type of endoscopy.

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age >= 18 yrs
• undergoing upper endoscopy procedure under general anesthesia without emergency
• informed written consent

Exclusion criteria

• emergency
• might impair gastrointestinal motility (intestinal obstruction, stenosis)
• diseases of the central and peripheral nervous system or neuromuscular diseases
• drug-induced gastric emptying disorders
• pregnancy
• ionic disorders (hyponatremia<125mmol/l ; hypokalemia<3,5mmol/l
• hemodynamic disorders (systolic arterial pressure <100mmHg)
• unstable diabetes (glycemia>2,5g/l) ± insulin- dependent diabetes ± diabetic gastroparesis
• the potential for difficult airway management
• understanding of the information
• patient with bad prognosis

Trial design

119 participants in 2 patient groups

No intervention

No Intervention group

Description:

Group overnight fasting

Group drink

Active Comparator group

Description:

Glucose drink (200 ml of fruit juice without pulp, ± 200ml coffee or tea, 2 at 4 hours before induction of anaesthesia)

Treatment:

Procedure: group drink