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

Sponsor

University Hospital, Geneva (Other)

Overall Status

Completed

CT.gov ID

NCT00827216

Collaborator

(none)

132

Enrollment

Location

Arms

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aspiration of Gastric Contents Gastric Emptying	Drug: Placebo Drug: Erythromycin	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

132 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Physiologic saline	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.
Active Comparator: Erythromycine	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. Other Names: Erythrocine®

Arm

Intervention/Treatment

Placebo Comparator: Physiologic saline

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.

Active Comparator: Erythromycine

Drug: Erythromycin

Other Names:

Erythrocine®

Outcome Measures

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). [10 minutes]

Secondary Outcome Measures

Acidity and Estimation of the volume of gastric content if stomach not empty (ml). [10 minutes]
Drug-related allergic reactions. [30 minutes]
Arrhythmia. [30 minutes]
Gastrointestinal cramps after study drug administration but before intubation. [30 minutes]
Nausea or vomiting after study drug administration but before intubation. [30 minutes]
Regurgitation with or without broncho-aspiration at induction. [30 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of Geneva	Geneva		Switzerland	1211

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