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

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

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.

Study Overview

• Status: Completed
• Conditions: Upper Gastrointestinal Endoscopy
• Intervention / Treatment: Procedure: group drink

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France, 14033
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No intervention; Group overnight fasting
Active Comparator: Group drink; Glucose drink (200 ml of fruit juice without pulp, ± 200ml coffee or tea, 2 at 4 hours before induction of anaesthesia)	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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Principal Investigator: Marie A PIQUET, PhD MD, CAEN, Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: October 18, 2011
• First Submitted That Met QC Criteria: November 10, 2011
• First Posted (Estimate): November 15, 2011

Study Record Updates

• Last Update Posted (Estimate): February 27, 2013
• Last Update Submitted That Met QC Criteria: February 26, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: general anesthesia; upper gastrointestinal endoscopy
• Other Study ID Numbers: 2008-A00255-50; 08-009 (Caen, Hospital)