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NCT02296866 Clinical Trial

Assessment of Prokinetic Effects of Erythromycin in Emergency Patients With a Full Stomach

Emergency Surgery Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02296866
Other study ID # 2013-A01257-38
Secondary ID
Status Completed
Phase N/A
First received November 18, 2014
Last updated December 26, 2014
Start date September 2014
Est. completion date November 2014

Study information
Verified date December 2014
Source Hôpital Edouard Herriot
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Observational

Clinical Trial Summary

The aims of the study is to assess whether the intravenous infusion of 3 mg/kg erythromycin has a significant gastrokinetic effect leading to empty the stomach in less than 90 minutes in non-fasting patients undergoing emergency trauma surgery.

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Emergency surgery for trauma

- ASA 1 and 2 patients

- Full stomach (antral area > 550 mm²)

- Adult patients

Exclusion Criteria:

- No contraindication to erythromycin

- Extreme emergency surgery (time frame < 90 min between arrival in the service and the start of the surgery)

- gastroparesis or pathology associated with gastroparesis

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
France Hopital Edouard Herriot Lyon

Sponsors (1)
Lead Sponsor Collaborator
Lionel Bouvet

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary ultrasonographic measurement of antral area 30 minutes and immediately before erythromycin infusion, and 30, 60 and 90 min after the start of erythromycin infusion No
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