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

NCT ID: NCT01471600

Last Updated: 2013-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2011-12-31

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.

Conditions

Upper Gastrointestinal Endoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

No intervention

Group overnight fasting

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group drink

Glucose drink (200 ml of fruit juice without pulp, ± 200ml coffee or tea, 2 at 4 hours before induction of anaesthesia)

Group Type: ACTIVE_COMPARATOR

group drink

Intervention Type: PROCEDURE

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

Interventions

group drink

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie A PIQUET, PhD MD

Role: PRINCIPAL_INVESTIGATOR

CAEN, Hospital

Locations

University Hospital

Caen, , France

Countries

France

Other Identifiers

08-009

Identifier Type: OTHER

Identifier Source: secondary_id

2008-A00255-50

Identifier Type: -

Identifier Source: org_study_id