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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00827216
• Other study ID #: NAC 06-225
• Secondary ID: Swissmedic 2008
• Status: Completed
• Phase: Phase 2
• First received: January 21, 2009
• Last updated: June 22, 2015
• Start date: January 2009
• Est. completion date: April 2013

Study information

• Verified date: June 2015
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aspiration of Gastric Contents
• Gastric Emptying

Intervention

Drug:
• Placebo
For all patients, a standardised volume of 10 ml of the study drug (will be diluted in 90 ml NaCl 0.9% (total volume, 100 ml). Both, the study drug and the 90 ml NaCl bag will be prepared by the pharmacy. Using sterile syringes, the investigator will withdraw from this solution as many millilitres as necessary to obtain a volume that corresponds to 1 ml per kg bodyweight of the patient (i.e. for a 67 kg patient, 33 ml would be with withdrawn). Thus, the maximum volume that can be administered to a patient will be 100 ml (i.e. for a patient weighing =100 kg). Twenty minutes prior to the scheduled induction of anaesthesia, patients will receive their study drug solution as an intravenous infusion during 5 min.
• Erythromycin
For all patients, a standardised volume of 10 ml of the study drug (will be diluted in 90 ml NaCl 0.9% (total volume, 100 ml). Both, the study drug and the 90 ml NaCl bag will be prepared by the pharmacy. Using sterile syringes, the investigator will withdraw from this solution as many millilitres as necessary to obtain a volume that corresponds to 1 ml per kg bodyweight of the patient (i.e. for a 67 kg patient, 33 ml would be with withdrawn). Thus, the maximum volume that can be administered to a patient will be 100 ml (i.e. for a patient weighing =100 kg). Twenty minutes prior to the scheduled induction of anaesthesia, patients will receive their study drug solution as an intravenous infusion during 5 min. The regimen corresponds to 3 mg/kg of erythromycin.

Locations

Country	Name	City	State
Switzerland	University Hospital of Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Czarnetzki C, Elia N, Frossard JL, Giostra E, Spahr L, Waeber JL, Pavlovic G, Lysakowski C, Tramèr MR. Erythromycin for Gastric Emptying in Patients Undergoing General Anesthesia for Emergency Surgery: A Randomized Clinical Trial. JAMA Surg. 2015 Aug;150( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		10 minutes	No
Secondary	Acidity and Estimation of the volume of gastric content if stomach not empty (ml).		10 minutes	No
Secondary	Drug-related allergic reactions.		30 minutes	Yes
Secondary	Arrhythmia.		30 minutes	Yes
Secondary	Gastrointestinal cramps after study drug administration but before intubation.		30 minutes	No
Secondary	Nausea or vomiting after study drug administration but before intubation.		30 minutes	No
Secondary	Regurgitation with or without broncho-aspiration at induction.		30 minutes	No

External Links

•   Jama Surgery Online first