Gastric pH in Intubated Children - Part Two

Study Overview
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Brief Summary
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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

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

Conditions
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Preoperative Fasting

Intervention / Treatment
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* Procedure: clear fluid ingestion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: clear fluids until premedication<br>allowed to drink until premedication, aprox 30 minutes before anaesthesia induction. Fasting for solids and non-clear fluids is six hours. | Procedure: clear fluid ingestion<br>* drinking of clear fluid in preoperative period<br>|
| Active Comparator: 2 hours fluid fasting<br>allowed to drink until 2 hour before scheduled anaesthesia induction clear fluid Ingestion. Fasting for solids and non-clear fluids is six hours. | Procedure: clear fluid ingestion<br>* drinking of clear fluid in preoperative period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gastric pH | 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 | within 10 min after tracheal intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gastric aspirate volume | 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 | within 10 min after tracheal intubation | 
| subjective feeling of hunger/thirst | subjective feeling of hunger/thirst given as yes or no answer | baseline | 
| Postoperative Nausea and Vomiting (PONV) in recovery unit |  | recovery period, on the average within 90 minutes after end of anaesthesia | 
| Behaviour during recovery period | 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) | recovery period, on the average within 90 minutes after end of anaesthesia | 
| Behaviour during anaesthesia induction | Rating scale1-5 by (blinded) anaesthetist: 1: cooperating - 2: anxious but cooperating - 3: hostile - 4: crying - 5: agitated/fighting | on the average within 20 minutes after arrival of patient in operating theatre | 
| Nurse's Impression of patient's satisfactory | subjective feeling of the Nurse regarding patient's satisfactory given as rating scale from 1 to 4 | baseline | 
| blood Ketone measurement | measurement of blood Ketone with a portable poc Ketone measurement device | intraoperative |