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Completed

NCT Number: NCT04682691

Effect of Metoclopramide Versus Erythromycin on 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

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Key information

Conditions

Gastric Residual Volume

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Cairo University.

Cairo, Egypt, 11451

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erythromycin (400mg)

Drug

oral Erythromycin (400mg)

metoclopramide (10mg)

Drug

oral metoclopramide (10mg)

naturally flavored water

Dietary Supplement

naturally flavored water

Primary outcomes

  1. Estimated Gastric volume

    Time frame: UP TO 6 HOURE

    (ml/kg) after a six-hour fast using Roukhomovsky's equation after administration of the study drug.

Secondary outcomes

  1. low-risk stomach six hours after drug administration

    Time frame: up to 6 hours

    number of patient and %

  2. Perlas grading system

    Time frame: UP TO 24 HOURE

    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

  3. Evaluation of the risk of aspiration

    Time frame: UP TO 24 HOURE

    residual gastric volume < 1.5 mL/kg

  4. quantitative gastric contents

    Time frame: up to 24 hours

    every one hours estimated GV till ( < 1.5 ml/kg) post-drug administration

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 24, 2020
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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