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Completed

NCT Number: NCT01133691

Examination of Gastric Emptying in Children

* Background: Fasting is mandatory for safety of anesthesia in elective surgery and imaging but gives rise to discomfort, hunger and thirst especially in children. Internationally accepted fasting times are often prolonged because of organisational delay in operating theatre. * Hypothesis: Clear fluids can be ingested until an imaginary anesthesia induction time without enlarging the residual gastric contents compared to overnight fast. There is no difference between residual gastric contents after 4 hours of fasting after a light meal compare to 6 hours in healthy children. * Examination of gastric volume using magnetic resonance imaging after overnight fasting and subsequent scans after either clear fluid intake or intake of a standard breakfast are performed in children aged 6 - 12 years. Time course after fluid intake is followed with scans every half hour for 2 hours. In the breakfast group 4 versus 6 hours fasting time will be simulated, e. g. intake of clear fluid is allowed for 2 versus 4 hours after the meal. Volume of gastric contents will be compared with a standardized ultrasonographic view of the stomach.

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Key information

Conditions

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Children's Hospital, Anesthesiology

Zurich, Canton of Zurich, 8032, Switzerland

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • age 6 - 12 years
  • ASA I or II

Exclusion criteria

  • gastrointestinal pathology
  • claustrophobia
  • implants like pacemaker, ventriculoperitoneal shunt etc
  • symptomatic or relevant cardiac, renal or metabolic disease

Treatment and study plan

clear fluid, light breakfast

Dietary Supplement

clear fluid 7 ml/kg, breakfast consisting of yoghurt, muesli, mild

Primary outcomes

  1. Gastric emptying time

    Time frame: 6 hours

    Time after food/fluid ingestion when gastric volume after overnight fast is achieved, as measured by volumetry of magnetic resonance scans

Secondary outcomes

  1. gastric volume after fasting

    Time frame: 6 hours

  2. gastric antral area

    Time frame: 6 hours

  3. visual analog scale of thirst/hunger

    Time frame: 6 hours

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Registry information

Official study title

Examination of Gastric Emptying With Magnetic Resonance Imaging and Ultrasonography

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 31, 2010
Registry last updated
Jan 18, 2012

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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