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

Upper Gastrointestinal Endoscopy Clinical Trial

— ENDOGLUcide  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01471600
• Other study ID #: 2008-A00255-50
• Secondary ID: 08-009
• Status: Completed
• Phase: N/A
• First received: October 18, 2011
• Last updated: February 26, 2013
• Start date: May 2008
• Est. completion date: December 2011

Study information

• Verified date: February 2013
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: December 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Upper Gastrointestinal Endoscopy

Intervention

Procedure:
• group drink
group glucose drink : 200 ml of fruit juice without pulp, ± 200ml coffee or tea, 2 at 4 hours before induction of anaesthesia

Locations

Country	Name	City	State
France	University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	occurrence of vomiting	occurrence of vomiting	The participants will be followed for the duration of hospital stay, an expected average of one day.	Yes