Effect of Metoclopramide Versus Erythromycin on on Gastric Residual Volume

NCT ID: NCT04682691

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2024-02-22

Brief 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

Conditions

Gastric Residual Volume

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Group (C)

will be receive flavored water in total volume 15 ml

Group Type: SHAM_COMPARATOR

naturally flavored water

Intervention Type: DIETARY_SUPPLEMENT

naturally flavored water

Group (M)

will be receive 10 ml of oral metoclopramide (10mg) + 5 ml of flavored water in total volume 15 ml

Group Type: ACTIVE_COMPARATOR

metoclopramide (10mg)

Intervention Type: DRUG

oral metoclopramide (10mg)

Group (E)

will be receive 10 ml of oral Erythromycin (400mg) + 5 ml of flavored water in total volume 15 ml

Group Type: ACTIVE_COMPARATOR

Erythromycin (400mg)

Intervention Type: DRUG

oral Erythromycin (400mg)

Interventions

Erythromycin (400mg)

oral Erythromycin (400mg)

Intervention Type: DRUG

metoclopramide (10mg)

oral metoclopramide (10mg)

Intervention Type: DRUG

naturally flavored water

naturally flavored water

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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)

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

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

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Amr Samir Wahdan

Lecturer of Anesthesia, Pain management and Surgical ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amr wahdan, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo university , Cairo, Egypt

Locations

Faculty of Medicine, Cairo University.

Cairo, Egypt, Egypt

Countries

Egypt

Other Identifiers

MS-381-2020

Identifier Type: -

Identifier Source: org_study_id