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

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Control Study : Safety and Efficacy of Carbohydrate Drink Ingested Two Hours Before Upper Endoscopy Under General Anaesthesia

Conditions
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Upper Gastrointestinal Endoscopy

Intervention / Treatment
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* Procedure: group drink


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No intervention<br>Group overnight fasting | |
| Active Comparator: Group drink<br>Glucose drink (200 ml of fruit juice without pulp, ± 200ml coffee or tea, 2 at 4 hours before induction of anaesthesia) | Procedure: group drink<br>* group glucose drink : 200 ml of fruit juice without pulp, ± 200ml coffee or tea, 2 at 4 hours before induction of anaesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of preoperative patients increasing the anxiety score just before anaesthesia (H0) | percentage of patients who increased the anxiety score (Visual Analogue Scale of Anxiety) just before anaesthesia. | at H0 (just before anaesthesia). The participants will be followed for the duration of hospital stay, an expected average of one day. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| discomfort (anxiety, thirst, hunger, nervousness, nausea, tiredness) assessed by visual analogue scale (VAS) just before anaesthesia | discomfort (anxiety, thirst, hunger, nervousness, nausea, tiredness) assessed by visual analogue scale (VAS from 0 to 100mmm) just before anaesthesia (at H0). | at H0 (just before anaesthesia). The participants will be followed for the duration of hospital stay, an expected average of one day. | 
| handgrip strength assessed by dynamometer just before anaesthesia | handgrip strength assessed by dynamometer just before anaesthesia | at H0 (just before anaesthesia). The participants will be followed for the duration of hospital stay, an expected average of one day. | 
| quality of endoscopy estimated by gastroenterologist by visual analogue scale (VAS from 0 to 100mm) | quality of endoscopy estimated by gastroenterologist by visual analogue scale (VAS from 0 to 100mm) | The participants will be followed for the duration of hospital stay, an expected average of one day. | 
| gastric residual volume (ml) | gastric residual volume (ml) | The participants will be followed for the duration of hospital stay, an expected average of one day. | 
| amount of propofol (mg) | the propofol consumption (mg) | The participants will be followed for the duration of hospital stay, an expected average of one day. | 
| gastric acidity (pH) | gastric acidity (pH) measured by pH indicator paper | The participants will be followed for the duration of hospital stay, an expected average of one day. | 
| occurrence of vomiting | occurrence of vomiting | The participants will be followed for the duration of hospital stay, an expected average of one day. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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upper gastrointestinal endoscopy, general anesthesia