Clinical trial NCT01471600: Safety and Efficacy of Carbohydrate Drink Ingested Two Hours Before Upper Endoscopy Under General Anaesthesia
Official title: Randomized Control Study : Safety and Efficacy of Carbohydrate Drink Ingested Two Hours Before Upper Endoscopy Under General Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Gastrointestinal Endoscopy
Keywords: upper gastrointestinal endoscopy
general anesthesia
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2011-11-15
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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

Primary outcomes:
measure: percentage of preoperative patients increasing the anxiety score just before anaesthesia (H0)
timeFrame: at H0 (just before anaesthesia). The participants will be followed for the duration of hospital stay, an expected average of one day.
Secondary outcomes:
measure: discomfort (anxiety, thirst, hunger, nervousness, nausea, tiredness) assessed by visual analogue scale (VAS) just before anaesthesia
timeFrame: at H0 (just before anaesthesia). The participants will be followed for the duration of hospital stay, an expected average of one day.
measure: handgrip strength assessed by dynamometer just before anaesthesia
timeFrame: at H0 (just before anaesthesia). The participants will be followed for the duration of hospital stay, an expected average of one day.
measure: quality of endoscopy estimated by gastroenterologist by visual analogue scale (VAS from 0 to 100mm)
timeFrame: The participants will be followed for the duration of hospital stay, an expected average of one day.
measure: gastric residual volume (ml)
timeFrame: The participants will be followed for the duration of hospital stay, an expected average of one day.
measure: amount of propofol (mg)
timeFrame: The participants will be followed for the duration of hospital stay, an expected average of one day.
measure: gastric acidity (pH)
timeFrame: The participants will be followed for the duration of hospital stay, an expected average of one day.
measure: occurrence of vomiting
timeFrame: The participants will be followed for the duration of hospital stay, an expected average of one day.
Other outcomes:
Locations:
city: Caen
country: France
facility: University Hospital
Study officials:
affiliation: CAEN, Hospital
name: Marie A PIQUET, PhD MD
role: PRINCIPAL_INVESTIGATOR
References: