Effect of Metoclopramide Versus Erythromycin on on Gastric Residual Volume

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

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

Study Overview

• Status: Completed
• Conditions: Gastric Residual Volume
• Intervention / Treatment: Dietary supplement: naturally flavored water; Drug: metoclopramide (10mg); Drug: Erythromycin (400mg)

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11451
    • Faculty of Medicine, Cairo University.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group (M); will be receive 10 ml of oral metoclopramide (10mg)	Drug: metoclopramide (10mg); oral metoclopramide (10mg)
Sham Comparator: Group (C); will be receive flavored water in total volume 15 ml	Dietary supplement: naturally flavored water; naturally flavored water
Active Comparator: Group (E); will be receive 10 ml of oral Erythromycin (400mg)	Drug: Erythromycin (400mg); oral Erythromycin (400mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
a low-risk stomach	number and percentage of patient low risk stomach	UP TO 6 HOURE

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Evaluation of the risk of aspiration	residual gastric volume < 1.5 mL/kg	UP TO 24 HOURE

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Amr wahdan, MD, Cairo university , Cairo, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): February 5, 2024
• Study Completion (Actual): February 22, 2024

Study Registration Dates

• First Submitted: December 19, 2020
• First Submitted That Met QC Criteria: December 19, 2020
• First Posted (Actual): December 24, 2020

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Erythromycin; Ultrasonography; Gastric Emptying; Metoclopramide
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antiemetics; Gastrointestinal Agents; Anti-Bacterial Agents; Dopamine Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Protein Synthesis Inhibitors; Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate; Metoclopramide
• Other Study ID Numbers: MS-381-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No