Gastric pH in Intubated Children - Part Two

University of Zurich (UZH)

Status: Completed

Conditions: Preoperative Fasting

Treatments: Procedure: clear fluid ingestion

Study type: Interventional

Funder types: Other

Identifiers

NCT02603094

KEK-ZH Nr. 2011-0034 Amend3

Details and patient eligibility

About

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

Enrollment: 180 patients

Sex: All

Ages: 1 to 15 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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180 participants in 2 patient groups

clear fluids until premedication

Experimental group

Description:

allowed to drink until premedication, aprox 30 minutes before anaesthesia induction. Fasting for solids and non-clear fluids is six hours.

Treatment:

Procedure: clear fluid ingestion

2 hours fluid fasting

Active Comparator group

Description:

allowed to drink until 2 hour before scheduled anaesthesia induction clear fluid Ingestion. Fasting for solids and non-clear fluids is six hours.

Treatment:

Procedure: clear fluid ingestion