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Completed

NCT Number: NCT01471600

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Caen, 14033, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. percentage of preoperative patients increasing the anxiety score just before anaesthesia (H0)

    Time frame: at H0 (just before anaesthesia). The participants will be followed for the duration of hospital stay, an expected average of one day.

    percentage of patients who increased the anxiety score (Visual Analogue Scale of Anxiety) just before anaesthesia.

Secondary outcomes

  1. discomfort (anxiety, thirst, hunger, nervousness, nausea, tiredness) assessed by visual analogue scale (VAS) just before anaesthesia

    Time frame: at H0 (just before anaesthesia). The participants will be followed for the duration of hospital stay, an expected average of one day.

    discomfort (anxiety, thirst, hunger, nervousness, nausea, tiredness) assessed by visual analogue scale (VAS from 0 to 100mmm) just before anaesthesia (at H0).

  2. handgrip strength assessed by dynamometer just before anaesthesia

    Time frame: 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

  3. quality of endoscopy estimated by gastroenterologist by visual analogue scale (VAS from 0 to 100mm)

    Time frame: 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)

  4. gastric residual volume (ml)

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

    gastric residual volume (ml)

  5. amount of propofol (mg)

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

    the propofol consumption (mg)

  6. gastric acidity (pH)

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

    gastric acidity (pH) measured by pH indicator paper

  7. occurrence of vomiting

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

    occurrence of vomiting

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Acronym: ENDOGLUcide

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Nov 15, 2011
Registry last updated
Feb 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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