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Completed

NCT Number: NCT01516775

Gastric pH in Intubated Children

Fasting (according to ASA, ESA or institutional guidelines) is an important strategy to minimize the risk of regurgitation, vomiting and pulmonary aspiration during general anaesthesia; the effect of fasting time for clear fluid on gastric pH in children is goal of this study and can be investigated in children undergoing elective procedures in intubation anaesthesia without inconvenience or additional invasive procedure and hence without additional risk

Hypotheses: Gastric pH is higher in children that drink until 1 hour before anaesthesia induction than in those that drink until 2 hours before anaesthesia induction

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Key information

Conditions

Preoperative Fasting Behavior Fasting Feeding Behavior

Age range

1 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Children's Hospital

Zurich, 4153, Switzerland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age > 1 / <= 16 years
  • ASA class I or II
  • elective surgery requiring general anaesthesia using tracheal intubation

Exclusion criteria

  • disease or dysfunction of gastrointestinal tract
  • chronic diseases or conditions not compatible with ASA class I or II

Treatment and study plan

clear fluid ingestion

Other

drinking of clear fluid in preoperative period

Primary outcomes

  1. gastric pH

    Time frame: within 10 min after tracheal intubation

    gastric pH is measured from gastric contents which is sampled in a syringe via an orogastric tube immediately during anaesthesia after tracheal intubation induction; suctioning of the stomach after intubation is a procedure routinely performed in every intubation child in our institution

Secondary outcomes

  1. subjective feeling of hunger/thirst

    Time frame: within 10 minutes after arrival of patient in operating theatre

    subjective feeling of hunger/thirst given as rating scale from 1 to 4

  2. gastric aspirate volume

    Time frame: within 10 min after tracheal intubation

    gastric aspirate volume is the amount of gastric contents which is sampled in a syringe via an orogastric tube immediately during anaesthesia after tracheal intubation induction; suctioning of the stomach after intubation is a procedure routinely performed in every intubation child in our institution

  3. Postoperative Nausea and Vomiting (PONV) in recovery unit

    Time frame: recovery period, on the average within 90 minutes after end of anaesthesia

  4. Behaviour during recovery period

    Time frame: recovery period, on the average within 90 minutes after end of anaesthesia

    Rating Scale 1 - 5 by blinded nurse (5: severely agitated/emergency delir with subsequent drug therapy, 4: agitated/emergeny delir; 3: slightly agitated; 2: complaining pain but cooperative; 1: cooperative)

  5. Behaviour during anaesthesia induction

    Time frame: on the average within 20 minutes after arrival of patient in operating theatre

    Rating scale 1 - 5 by (blinded) anaesthetist: 1: cooperating - 2: anxious but cooperating - 3: hostile - 4: crying - 5: agitated/fighting

Sponsors and collaborators

Lead sponsor

Achim Schmitz

Other

Registry information

Official study title

Untersuchung Des Magen-pH in Intubationsanästhesie Bei Kindern

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 25, 2012
Registry last updated
Oct 1, 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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