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Completed

NCT Number: NCT02603094

Gastric pH in Intubated Children - Part Two

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 general anaesthesia and intubation without inconvenience or additional invasive procedure and hence without additional risk

Hypotheses: Gastric pH is higher in children that drink clear fluids until premedication before anaesthesia induction than in those that drink until 2 hours before anaesthesia induction

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Key information

Conditions

Preoperative Fasting

Age range

1 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Childrens Hospital

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 > 1 / < 16 years ASA class l or ll 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 l or ll

Treatment and study plan

clear fluid ingestion

Procedure

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. 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

  2. subjective feeling of hunger/thirst

    Time frame: baseline

    subjective feeling of hunger/thirst given as "yes" or "no" answer

  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 Scale1-5 by blinded nurse (5: severely agitated/emergence delir with subsequent drug therapy, 4: agitated/emergence 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 scale1-5 by (blinded) anaesthetist: 1: cooperating - 2: anxious but cooperating - 3: hostile - 4: crying - 5: agitated/fighting

  6. Nurse's Impression of patient's satisfactory

    Time frame: baseline

    subjective feeling of the Nurse regarding patient's satisfactory given as rating scale from 1 to 4

  7. blood Ketone measurement

    Time frame: intraoperative

    measurement of blood Ketone with a portable poc Ketone measurement device

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Registry information

Official study title

Untersuchung Des Magen-pH in lntubationsanästhesie Bei Kindern - Teil Zwei

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 11, 2015
Registry last updated
Sep 19, 2016

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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