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| ID | Type | Description | Link |
|---|---|---|---|
| 08-009 | Other Identifier | Caen, Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No intervention | No Intervention | Group overnight fasting | |
| Group drink | Active Comparator | Glucose drink (200 ml of fruit juice without pulp, ± 200ml coffee or tea, 2 at 4 hours before induction of anaesthesia) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| group drink | Procedure | group glucose drink : 200 ml of fruit juice without pulp, ± 200ml coffee or tea, 2 at 4 hours before induction of anaesthesia |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie A PIQUET, PhD MD | CAEN, Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Caen | 14033 | France |
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| 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. |