Clinical trial NCT00827216: The Effect of Intravenous Erythromycin on Gastric Emptying in Non-fasted Patients Before Emergency Total Anesthesia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Aspiration of Gastric Contents
Gastric Emptying
Keywords: Gastric emptying
emergency anesthesia
intravenous erythromycin
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2009-01-22
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: 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).
timeFrame: 10 minutes
Secondary outcomes:
measure: Acidity and Estimation of the volume of gastric content if stomach not empty (ml).
timeFrame: 10 minutes
measure: Drug-related allergic reactions.
timeFrame: 30 minutes
measure: Arrhythmia.
timeFrame: 30 minutes
measure: Gastrointestinal cramps after study drug administration but before intubation.
timeFrame: 30 minutes
measure: Nausea or vomiting after study drug administration but before intubation.
timeFrame: 30 minutes
measure: Regurgitation with or without broncho-aspiration at induction.
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospital of Geneva
Study officials:
affiliation: Division of Anesthesiology, University Hospital of Geneva
name: Christoph A Czarnetzki, MD, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Anesthesiology, University Hospital of Geneva
name: Martin R Tramer, MD, PhD
role: STUDY_CHAIR
References:
citation: Czarnetzki C, Elia N, Frossard JL, Giostra E, Spahr L, Waeber JL, Pavlovic G, Lysakowski C, Tramer MR. Erythromycin for Gastric Emptying in Patients Undergoing General Anesthesia for Emergency Surgery: A Randomized Clinical Trial. JAMA Surg. 2015 Aug;150(8):730-7. doi: 10.1001/jamasurg.2015.0306.