Gastric Emptying Clinical Trial
Official title:
The Effect of Intravenous Erythromycin on Gastric Emptying in Patients Undergoing Rapid Sequence Intubation for Full Stomach - A Randomised, Placebo-controlled, Double-blind Study
In this study the investigators want to investigate the effect of a short intravenous infusion of Erythromycine on gastric emptying on patients considered "full stomac" and scheduled for Emergency operation. A gastroscopy will be done after intubation to controll the effect of the perfusion.
Urgent or emergency surgery requires that fasting rules observed in elective settings are
not respected. Patients who are anesthetized in such conditions are at risk for
regurgitation and subsequent broncho-aspiration during induction of anaesthesia due to a
full stomach; they often have ingested food or liquids before the injury, or they may have
swallowed blood from oral or nasal injuries. Also, gastric emptying is delayed in these
patients due to the stress of trauma.1 Already in 1946, Mendelson described the consequences
of bronchoaspiration.2 Since, anaesthetists and emergency physicians have tried to avoid
broncho-aspiration in emergency patients using premedication with pro-kinetic drugs (for
instance, metoclopramide) or its complications with antacid substances, and through the use
of a rapid sequence intubation procedure with cricoid pressure.
The incidence of aspiration is low, about 1.4 to 6 in 10'000 anaesthetics.3 About 6 in
100'000 anaesthetics will lead to a pulmonary complication due to broncho-aspiration and
about 1 in 100'000 patients is likely to die due to aspiration.4 Thus, although episodes of
broncho-aspiration are rare, efficacious prevention of this potentially lethal complication
is important. One method to reduce the risk of broncho-aspiration during induction of
anaesthesia is the pharmacological reduction of the gastric content (i.e. pre-treatment).
The primary objective of this study is to investigate the effect of a short intravenous
infusion of erythromycin 3 mg/kg, administered 20 min before intubation on gastric emptying,
in adults scheduled for rapid sequence intubation for full stomach. After intubation a
gastroscopy will be done to see if there is any content in the stomac. The secondary
objective is the assessment of tolerability and safety of a single intravenous dose of
preoperative erythromycin in surgical patients.
This study is a single centre, stratified (according to emergency setting), randomised,
placebo-controlled, double-blinded study.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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