The Effect of Intravenous Erythromycin on Gastric Emptying in Non-Fasted Patients Before Emergency Total Anesthesia

Condition(s) targeted: Aspiration of Gastric Contents; Gastric Emptying

Intervention: Placebo (Drug); Erythromycin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University Hospital, Geneva

Official(s) and/or principal investigator(s):
Christoph A Czarnetzki, MD, MBA, Principal Investigator, Affiliation: Division of Anesthesiology, University Hospital of Geneva
Martin R Tramer, MD, PhD, Study Chair, Affiliation: Division of Anesthesiology, University Hospital of Geneva

Overall contact:
Christoph A Czarnetzki, MD, MBA, Phone: 0041223733311, Email: christoph.czarnetzki@hcuge.ch

Urgent or emergency surgery requires that fasting rules observed in elective settings are not respected. Patients in the emergency situation have often ingested food or liquids in their stomach and may have swallowed blood from oral or nasal injuries. Also, gastric emptying is delayed due to the stress of trauma. Patients who are anesthetized in such conditions are at risk of "vomiting" (regurgitation) during the start of anesthesia and that the content of the stomach reaches the trachea and lungs (this is called bronchoaspiration). Fortunately the incidence of aspiration is low, about 1. 4 to 6 in 10'000 anaesthetics, and about 1 in 100'000 patients is likely to die due to aspiration. 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 intention of this study is to investigate the efficacy of erythromycin in emptying the stomach of non-fasted surgical patients before induction of anaesthesia in the emergency setting.

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study

Primary outcome: Immediately after intubation an upper GI endoscopy will be done. The following primary endpoint will be recorded: Stomach clear from any content: yes or no (dichotomous).

Secondary outcome:

Acidity and Estimation of the volume of gastric content if stomach not empty (ml).

Drug-related allergic reactions.

Arrhythmia.

Gastrointestinal cramps after study drug administration but before intubation.

Nausea or vomiting after study drug administration but before intubation.

Regurgitation with or without broncho-aspiration at induction.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Adults, age ≥18 years, male or female.

- American Society of Anaesthesiology [ASA] status I, II or III.

- Non-starving patients presenting for surgery.

- Patients able to read and understand the information sheet and to sign the consent

form.

- If the patient is female and of childbearing potential, she must have a negative

pregnancy test

Exclusion Criteria:

- A history of allergy or hypersensitivity to erythromycin or other macrolides.

- Concomitant use of terfenadine, astemizole, cisapride, pimozid, cyclosporine,

clarithromycine.

- Patient with acute intermittent porphyria.

- Acute or subacute necrosis of the liver, acute or subacute hepatitis, acute liver

trauma

- Acute renal failure, acute glomerulonephritis, nephritic syndrome, chronic renal

failure with electrolyte disorders, uremia

- Exacerbated asthma, exacerbated chronic obstructive lung disease, acute pulmonary

infection

- Coronary heart disease (unstable angina, MI within the last 6 months), decompensated

cardiac insufficiency, aortic aneurysm

- Polyneuropathy (for instance, due to diabetes mellitus)

- Patients with oesophageal and pharyngeal disease (i. e. oesophageal varices,

oesophageal and pharyngeal cancer, Zenker's diverticulum).

- Status after gastric surgery, gastric bypass surgery, Nissen operation

- Patients with life threatening illness or injury needing immediate surgery

- Patients with moderate to severe head trauma (GCS on admission <13)

- Psychological or psychiatric disorders.

- Dementia or inability to understand the study protocol.

- Women who are pregnant or are breast feeding.

- Patient scheduled for ileus surgery.

Christoph A Czarnetzki, MD, MBA, Phone: 0041223733311, Email: christoph.czarnetzki@hcuge.ch

University Hospital of Geneva, Geneva 1211, Switzerland; Recruiting
Christoph A Czarnetzki, MD, MBA, Phone: 0041223723311, Ext: 7958558, Email: christoph.czarnetzki@hcuge.ch
Martin R Tramèr, MD, Dphil, Phone: 0041223723311, Ext: 7958621, Email: martin.tramer@hcuge.ch
Jean Luc Waeber, MD, Sub-Investigator
Christopher Lysakowski, MD, Sub-Investigator
Georges Savoldelli, MD, Sub-Investigator
Emiliano Giostra, MD, Sub-Investigator
Jean Louis Frossard, MD, Sub-Investigator
Laurent Spahr, MD, Sub-Investigator

Related publications:

Frossard JL, Spahr L, Queneau PE, Giostra E, Burckhardt B, Ory G, De Saussure P, Armenian B, De Peyer R, Hadengue A. Erythromycin intravenous bolus infusion in acute upper gastrointestinal bleeding: a randomized, controlled, double-blind trial. Gastroenterology. 2002 Jul;123(1):17-23. Erratum in: Gastroenterology 2002 Dec;123(6):2162.

Boivin MA, Carey MC, Levy H. Erythromycin accelerates gastric emptying in a dose-response manner in healthy subjects. Pharmacotherapy. 2003 Jan;23(1):5-8.

Bouvet L, Duflo F, Bleyzac N, Mion F, Boselli E, Allaouchiche B, Chassard D. Erythromycin promotes gastric emptying during acute pain in volunteers. Anesth Analg. 2006 Jun;102(6):1803-8.

Kopp VJ, Mayer DC, Shaheen NJ. Intravenous erythromycin promotes gastric emptying prior to emergency anesthesia. Anesthesiology. 1997 Sep;87(3):703-5. No abstract available.

Starting date: January 2009
Ending date: January 2010
Last updated: January 22, 2009