Upper Gastrointestinal Endoscopy
Conditions
Keywords
upper gastrointestinal endoscopy, general anesthesia
Brief summary
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.
Interventions
PROCEDUREgroup drink
group glucose drink : 200 ml of fruit juice without pulp, ± 200ml coffee or tea, 2 at 4 hours before induction of anaesthesia
Sponsors
University Hospital, Caen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percentage of preoperative patients increasing the anxiety score just before anaesthesia (H0) | at H0 (just before anaesthesia). The participants will be followed for the duration of hospital stay, an expected average of one day. | percentage of patients who increased the anxiety score (Visual Analogue Scale of Anxiety) just before anaesthesia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | handgrip strength assessed by dynamometer just before anaesthesia |
| 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. | quality of endoscopy estimated by gastroenterologist by visual analogue scale (VAS from 0 to 100mm) |
| gastric residual volume (ml) | The participants will be followed for the duration of hospital stay, an expected average of one day. | gastric residual volume (ml) |
| discomfort (anxiety, thirst, hunger, nervousness, nausea, tiredness) assessed by visual analogue scale (VAS) 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. | discomfort (anxiety, thirst, hunger, nervousness, nausea, tiredness) assessed by visual analogue scale (VAS from 0 to 100mmm) just before anaesthesia (at H0). |
| gastric acidity (pH) | The participants will be followed for the duration of hospital stay, an expected average of one day. | gastric acidity (pH) measured by pH indicator paper |
| occurrence of vomiting | The participants will be followed for the duration of hospital stay, an expected average of one day. | occurrence of vomiting |
| amount of propofol (mg) | The participants will be followed for the duration of hospital stay, an expected average of one day. | the propofol consumption (mg) |
Countries
France
Outcome results
None listed