Gastric pH in Intubated Children

Achim Schmitz

Status: Completed

Conditions: Preoperative Fasting

Treatments: Other: clear fluid ingestion

Study type: Interventional

Funder types: Other

Identifiers

NCT01516775

KEK-ZH Nr. 2011-0034

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 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

Enrollment: 150 patients

Sex: All

Ages: 1 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

1 hour fluid fasting

Experimental group

Description:

allowed to drink until 1 hour before scheduled anaesthesia induction

Treatment:

Other: clear fluid ingestion

2 hours fluid fasting

Active Comparator group

Description:

allowed to drink until 2 hour before scheduled anaesthesia induction

Treatment:

Other: clear fluid ingestion