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

Sponsored by:	University Hospital, Geneva
Information provided by:	University Hospital, Geneva
ClinicalTrials.gov Identifier:	NCT00827216

Purpose

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.

Condition	Intervention	Phase
Aspiration of Gastric Contents Gastric Emptying	Drug: Placebo Drug: Erythromycin	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia Nausea and Vomiting

Drug Information available for: Erythromycin Gluceptate Erythromycin Erythromycin stearate Erythromycin ethylsuccinate Erythromycin estolate

U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:

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). [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Acidity and Estimation of the volume of gastric content if stomach not empty (ml). [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
Drug-related allergic reactions. [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
Arrhythmia. [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
Gastrointestinal cramps after study drug administration but before intubation. [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
Nausea or vomiting after study drug administration but before intubation. [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
Regurgitation with or without broncho-aspiration at induction. [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	January 2009
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Placebo Comparator	Drug: Placebo 10 ml syringes of placebo (0.9% saline) will be prepared every two weeks and stored at 2-8ºC.
B: Active Comparator	Drug: Erythromycin 10 ml syringes of erythromycin 3% will be prepared every two weeks and stored at 2-8ºC.The study drug will be diluted in 90 ml NaCl 0.9% (total volume, 100 ml). Twenty minutes prior to scheduled induction of anaesthesia, patients will receive 1 ml/kg (maximum 100 ml) of that solution as an intravenous infusion during 5 min. The regimen corresponds to 3 mg/kg; the maximum dose will be 300 mg.

Arms

Assigned Interventions

A: Placebo Comparator

Drug: Placebo

10 ml syringes of placebo (0.9% saline) will be prepared every two weeks and stored at 2-8ºC.

B: Active Comparator

Drug: Erythromycin

10 ml syringes of erythromycin 3% will be prepared every two weeks and stored at 2-8ºC.The study drug will be diluted in 90 ml NaCl 0.9% (total volume, 100 ml). Twenty minutes prior to scheduled induction of anaesthesia, patients will receive 1 ml/kg (maximum 100 ml) of that solution as an intravenous infusion during 5 min. The regimen corresponds to 3 mg/kg; the maximum dose will be 300 mg.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00827216

Contacts

Contact: Christoph A Czarnetzki, MD, MBA	0041223733311	christoph.czarnetzki@hcuge.ch
Contact: Martin R Tramer, MD, PhD	0041223723311	martin.tramer@hcuge.ch

Locations

Switzerland
University Hospital of Geneva	Recruiting
Geneva, Switzerland, 1211
Contact: Christoph A Czarnetzki, MD, MBA 0041223723311 ext 7958558 christoph.czarnetzki@hcuge.ch
Contact: Martin R Tramèr, MD, Dphil 0041223723311 ext 7958621 martin.tramer@hcuge.ch
Sub-Investigator: 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

Sponsors and Collaborators

University Hospital, Geneva

Investigators

Principal Investigator:	Christoph A Czarnetzki, MD, MBA	Division of Anesthesiology, University Hospital of Geneva
Study Chair:	Martin R Tramer, MD, PhD	Division of Anesthesiology, University Hospital of Geneva

More Information

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.

Responsible Party:	Division of Anesthesiology, University Hospitals of Geneva ( Christoph Czarnetzki, MD, MBA )
Study ID Numbers:	NAC 06-225, Swissmedic 2008 DR 2321
Study First Received:	January 21, 2009
Last Updated:	January 22, 2009
ClinicalTrials.gov Identifier:	NCT00827216 History of Changes
Health Authority:	Switzerland: Swissmedic

Keywords provided by University Hospital, Geneva:

Gastric emptying
emergency anesthesia
gastric emptying
intravenous erythromycin

Study placed in the following topic categories:

Erythromycin stearate
Anti-Infective Agents
Erythromycin Ethylsuccinate
Respiration Disorders
Central Nervous System Depressants
Anesthetics
Respiratory Aspiration
Pneumonia, Aspiration
Erythromycin

Anti-Bacterial Agents
Signs and Symptoms
Respiratory Tract Diseases
Respiratory Tract Infections
Erythromycin Estolate
Lung Diseases
Emergencies
Signs and Symptoms, Respiratory
Pneumonia

Additional relevant MeSH terms:

Erythromycin stearate
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Erythromycin Ethylsuccinate
Physiological Effects of Drugs
Anesthetics
Respiratory Aspiration
Signs and Symptoms
Anti-Bacterial Agents
Respiratory Tract Infections
Respiratory Tract Diseases
Therapeutic Uses
Signs and Symptoms, Respiratory

Respiration Disorders
Gastrointestinal Agents
Central Nervous System Depressants
Pneumonia, Aspiration
Enzyme Inhibitors
Erythromycin
Pharmacologic Actions
Protein Synthesis Inhibitors
Erythromycin Estolate
Lung Diseases
Central Nervous System Agents
Pneumonia

ClinicalTrials.gov processed this record on September 11, 2009