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Gastric pH in Intubated Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Achim Schmitz, University Children's Hospital, Zurich
ClinicalTrials.gov Identifier:
NCT01516775
First received: January 16, 2012
Last updated: September 28, 2012
Last verified: September 2012

January 16, 2012
September 28, 2012
January 2012
September 2012   (final data collection date for primary outcome measure)
gastric pH [ Time Frame: within 10 min after tracheal intubation ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01516775 on ClinicalTrials.gov Archive Site
  • subjective feeling of hunger/thirst [ Time Frame: within 10 minutes after arrival of patient in operating theatre ] [ Designated as safety issue: No ]
    subjective feeling of hunger/thirst given as rating scale from 1 to 4
  • gastric aspirate volume [ Time Frame: within 10 min after tracheal intubation ] [ Designated as safety issue: No ]
    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
  • Postoperative Nausea and Vomiting (PONV) in recovery unit [ Time Frame: recovery period, on the average within 90 minutes after end of anaesthesia ] [ Designated as safety issue: No ]
  • Behaviour during recovery period [ Time Frame: recovery period, on the average within 90 minutes after end of anaesthesia ] [ Designated as safety issue: No ]
    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)
  • Behaviour during anaesthesia induction [ Time Frame: on the average within 20 minutes after arrival of patient in operating theatre ] [ Designated as safety issue: No ]
    Rating scale 1 - 5 by (blinded) anaesthetist: 1: cooperating - 2: anxious but cooperating - 3: hostile - 4: crying - 5: agitated/fighting
Same as current
Not Provided
Not Provided
 
Gastric pH in Intubated Children
Untersuchung Des Magen-pH in Intubationsanästhesie Bei Kindern

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Preoperative Fasting
Other: clear fluid ingestion
drinking of clear fluid in preoperative period
  • Experimental: 1 hour fluid fasting
    allowed to drink until 1 hour before scheduled anaesthesia induction
    Intervention: Other: clear fluid ingestion
  • Active Comparator: 2 hours fluid fasting
    allowed to drink until 2 hour before scheduled anaesthesia induction
    Intervention: Other: clear fluid ingestion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
1 Year to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01516775
KEK-ZH Nr. 2011-0034
No
Achim Schmitz, University Children's Hospital, Zurich
Achim Schmitz
Not Provided
Principal Investigator: Achim J Schmitz, MD University Children's Hospital Zurich, Switzerland
University Children's Hospital, Zurich
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP