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

NCT01471600 | Completed DMC

• 2 other identifiers: 2008-A00255-5008-009
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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

Keywords

upper gastrointestinal endoscopy; general anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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.

• 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)

  The participants will be followed for the duration of hospital stay, an expected average of one day.

• 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 participants will be followed for the duration of hospital stay, an expected average of one day.

Study Arms (2)

No intervention

NO INTERVENTION

Group overnight fasting

Group drink

ACTIVE COMPARATOR

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

Procedure: group drink

Interventions

group drink PROCEDURE

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

Group drink

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \>= 18 yrs
• undergoing upper endoscopy procedure under general anesthesia without emergency
• informed written consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

University Hospital

Caen, 14033, France

Location

Study Officials

• Marie A PIQUET, PhD MD

  CAEN, Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2011
• First Posted: November 15, 2011
• Study Start: May 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 27, 2013

Record last verified: 2013-02

Locations

FR (1)