Trial document





This trial has been registered retrospectively.
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  DRKS00005020

Trial Description

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Title

Evaluation of gastric volumen changes in dependence of the prefasting time

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

With this study we do hope to further demonstrate the safety of consumption of clear fluids up to two hours preoperatively. We will evaluate the gastric volume and pH and correlate it to the preoperative fasting time. Therefore, we evaluate the difference in the gastric volume and pH in 120 children, who undergo a routine gastroscopy in general anaesthesia. The first group ( 60 patients) will adhere to the regular preoperative fasting period. The second group of another 60 patients will be allowed to consume a PreOp-drink in the evening and up to two hours before the procedure.
Further we want to evaluate the incidence of postoperative nausea and vomiting (PONV) and the influence of PreOp on hunger, thirst, tiredness and weakness, in comparison with normal fasting.

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Brief Summary in Scientific Language

Background Information. Process optimization offers the opportunity to improve quality, safety and efficiency of medical care. Various approaches exist in a pre-, peri- and postoperative care setting. One important preoperative safety procedure is the preoperative fasting period.
Children, like adults, are required to fast before general anaesthesia to reduce volume and acidity of their stomach contents. It is generally accepted that fasting reduces the risk of regurgitation and aspiration of gastric contents during induction of anaesthesia and surgery. Paediatric fasting guidelines at our institution are 6h for solids, 4h for breast milk, and 2h for clear fluids, which is consistent with the guidelines of the Scandinavian preoperative fasting guidelines.
Undergoing a surgical procedure can be a tiring and stressful event for the children and their parents. The small patients are removed from their daily routine and fear of the procedure, can cause anxiety as well as uncooperative behaviour, which complicates the safe performances of the anaesthesiological and surgical procedures. Additionally excessive preoperative fasting times can increase the anxiety levels of the patients and further decrease the patients’ compliance for the necessary preoperative procedures, especially for very small children.
In the literature no increase in complications like pulmonal aspiration can be found, if preoperative fasting guidelines are modified to a less strict timeframe. The emptying time of clear fluids is about 30 minutes in children. It has been evaluated by Schmitz et al. using magnetic resonance imaging (MRI).

Long preoperative fasting periods can have additional deleterious effects. A prolonged fasting time can increase postoperative nausea and vomiting (PONV) in children (increasing by the age of the patient). The reduction of postoperative pain in paediatric patients after tonsillectomy have also been described after preoperative fasting periods. Moreover, Faria et al could demonstrate diminished insulin resistance in young women after consumption of a carbohydrate beverage two hours preoperative. Preoperative intake of a glutamine (GLN) plus a carbohydrate (CHO) beverage appears to improve insulin resistance (IR) and antioxidant defences and decreases the inflammatory response after video-cholecystectomy.

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Organizational Data

  •   DRKS00005020
  •   2014/05/19
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  •   yes
  •   Approved
  •   1622/2013, Ethikkommission der Medizinischen Universität Wien
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Secondary IDs

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Health Condition or Problem studied

  •   gastric problems
  •   K50 -  Crohn disease [regional enteritis]
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Interventions/Observational Groups

  •   For 60 children the routine fasting periods are respected. 6h for food or longer, 4h for breast milk and formula and if needed 2h for water.
  •   For 60 children the routine fasting periods are respected. 6h for food or longer, 4h for breast milk and formula and if needed 2h for water. In the evening and two hours preoperative that group get also a carbohydrate-rich juice ( PreOp 5ml/kgKG) to drink.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Other
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

With this study we do hope to further demonstrate the safety of preoperative consumption of clear fluids up to two hours preoperatively. For this purpose we will collect the gastric fluid during gastroscopy for measuring the volume and pH.

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Secondary Outcome

A second aim is to analyze a possible difference in the incidence of postoperative nausea and vomiting (PONV) between the two groups in correlation to the different fasting periods.

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Countries of Recruitment

  •   Austria
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/02/20
  •   120
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   2   Years
  •   18   Years
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Additional Inclusion Criteria

- Age 2-18 years
- Routine planned gastroscopy

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Exclusion Criteria

- Diabetes
- Acute or chronic upper gastrointestinal obstruction
- Conditions with increased abdominal pressure (e.g. ascites)
- Gastric acid blocker therapy
- Cortison therapy
- Patients who need a rapid sequence induction

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Addresses

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    • Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie
    • Mr.  Univ.- Prof. Dr.  Klaus  Markstaller 
    • Währinger Gürtel 18-20
    • 1090  Wien
    • Austria
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    • AKH Wien
    • Mr.  Ass.Prof, Priv.Doz. Dr.med.univ  Georg  Roth 
    • Währinger Gürtel 18-20
    • 1090  Wien
    • Austria
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    • AKH Wien
    • Mr.  Ass.Prof,Priv.Doz. Dr.med.univ  Georg  Roth 
    • Währinger Gürtel 18-20
    • 1090  Wien
    • Austria
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Sources of Monetary or Material Support

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    • Medizinische Universität Wien
    • Währinger-Gürtel 18-20
    • 1090  Wien
    • Austria
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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