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

NCT00827216 | Completed Phase 2

• 2 other identifiers: NAC 06-225Swissmedic 2008 DR 2321
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Aspiration of Gastric Contents; Gastric Emptying

Keywords

Gastric emptying; emergency anesthesia; intravenous erythromycin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

Physiologic saline

PLACEBO COMPARATOR

Drug: Placebo

Erythromycine

ACTIVE COMPARATOR

Drug: Erythromycin

Interventions

Placebo 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a volume that corresponds to 1 ml per kg bodyweight of the patient (i.e. for a 67 kg patient, 33 ml would be with withdrawn).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.

Physiologic saline

Erythromycin 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.

Also known as: Erythrocine®

Erythromycine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

University Hospital of Geneva

Geneva, 1211, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 26083537 RESULT

MeSH Terms

Interventions

Erythromycin

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Christoph A Czarnetzki, MD, MBA

  Division of Anesthesiology, University Hospital of Geneva

  PRINCIPAL INVESTIGATOR

• Martin R Tramer, MD, PhD

  Division of Anesthesiology, University Hospital of Geneva

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Responsable Investigator

Study Record Dates

• First Submitted: January 21, 2009
• First Posted: January 22, 2009
• Study Start: January 1, 2009
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: June 23, 2015

Record last verified: 2015-06

Locations

CH (1)