Status:
COMPLETED
The Effect of Intravenous Erythromycin on Gastric Emptying in Non-fasted Patients Before Emergency Total Anesthesia
Lead Sponsor:
University Hospital, Geneva
Conditions:
Aspiration of Gastric Contents
Gastric Emptying
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ope...
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 b...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00827216
Start Date
January 1 2009
End Date
April 1 2013
Last Update
June 23 2015
Active Locations (1)
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1
University Hospital of Geneva
Geneva, Switzerland, 1211