Effect of Metoclopramide Versus Erythromycin on on Gastric Residual Volume

Gastric Residual Volume Clinical Trial

Official title:

Comparison of the Effect of Metoclopramide Versus Erythromycin on Gastric Residual Volume

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04682691
• Other study ID #: MS-381-2020
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2021
• Est. completion date: February 22, 2024

Study information

• Verified date: March 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In emergencies, it may be necessary to anaesthetize who are not fully starved and consequently at risk of pulmonary aspiration. Pregnancy are recognized to be at increased risk of aspiration compared with non-pregnancy. Prokinetic agents such as metoclopramide can be used to reduce GRV. Metoclopramide is widely used as a prokinetic agent in adults and is licensed for premedication in pregnancy, but its use may be limited by its potential for producing extrapyramidal side effects. Erythromycin is an effective prokinetic agent in adults but there is no work examining its use for premedication in pregnancy. This study compared the effects of erythromycin and metoclopramide on GRV in full-term pregnant women

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 22, 2024
• Est. primary completion date: February 5, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Non-laboring pregnant women =36 weeks gestational age
• Parturient scheduled for elective caesarian delivery.
• Singleton pregnancy
• Age greater than 18 years
• Having followed institutional fasting guidelines (a minimum of 2 h for clear fluids, 6 h for a light meal, and 8 h for a meal that included fried or fatty food)

2. Exclusion criteria:

• Refusal of the patient
• Deviation from fasting times
• Patients with empty stomach
• Emergency operation
• Body mass index (BMI) greater than 40 kg/m2
• American Society of Anesthesiologists (ASA) physical status class III, IV.
• Gestational diabetes mellitus
• Multiple gestations
• Patients with polyhydramnios liquor.
• Preeclampsia patients
• Chronic kidney disease patients
• Systemic diseases may cause delayed gastric emptying (eg: myopathies and myasthenia gravis).
• Patients with gastrointestinal diseases such as hiatus hernia, intestinal disease and gastro-oesophageal reflux disease and patients with history of upper gastrointestinal surgeries.
• Patients on antidepressants and monoamine oxidase inhibitors
• Use of other medications known to affect gastric motility or secretions.
• Allergy to macrolide or metoclopramide

Related Conditions & MeSH terms

• Gastric Residual Volume

Intervention

Drug:
• Erythromycin (400mg)
oral Erythromycin (400mg)
• metoclopramide (10mg)
oral metoclopramide (10mg)

Dietary Supplement:
• naturally flavored water
naturally flavored water

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Cairo University.	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a low-risk stomach	number and percentage of patient low risk stomach	UP TO 6 HOURE
Secondary	Estimated Gastric volume	(mL) based on the antral CSA in the RLD by gastric ultrasonic after administration of the study drug.	UP TO 24 HOURE
Secondary	Perlas grading system	Grade 0 antrum: absent fluid content in both supine and RLD positions Grade 1 antrum: fluid is observed only in the RLD position, but not in the supine position Grade 2 antrum: fluid is observed in both supine and RLD	UP TO 24 HOURE
Secondary	Evaluation of the risk of aspiration	residual gastric volume < 1.5 mL/kg	UP TO 24 HOURE