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

NCT ID: NCT00827216

Last Updated: 2015-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2013-04-30

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.

Conditions

Aspiration of Gastric Contents; Gastric Emptying

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Physiologic saline

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Erythromycine

Group Type: ACTIVE_COMPARATOR

Erythromycin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Erythrocine®

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Christoph Czarnetzki

Responsable Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christoph A Czarnetzki, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Division of Anesthesiology, University Hospital of Geneva

Martin R Tramer, MD, PhD

Role: STUDY_CHAIR

Division of Anesthesiology, University Hospital of Geneva

Locations

University Hospital of Geneva

Geneva, , Switzerland

Countries

Switzerland

References

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.

Reference Type: RESULT

PMID: 26083537 (View on PubMed)

Other Identifiers

Swissmedic 2008 DR 2321

Identifier Type: OTHER

Identifier Source: secondary_id

NAC 06-225

Identifier Type: -

Identifier Source: org_study_id