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Effect of Metoclopramide Versus Erythromycin on on Gastric Residual Volume

Cairo University (CU) logo

Cairo University (CU)

Status

Completed

Conditions

Gastric Residual Volume

Treatments

Dietary Supplement: naturally flavored water
Drug: Erythromycin (400mg)
Drug: metoclopramide (10mg)

Study type

Interventional

Funder types

Other

Identifiers

NCT04682691
MS-381-2020

Details and patient eligibility

About

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

Enrollment

50 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)

    1. 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

50 participants in 3 patient groups

Group (C)
Sham Comparator group
Description:
will be receive flavored water in total volume 15 ml
Treatment:
Dietary Supplement: naturally flavored water
Group (M)
Active Comparator group
Description:
will be receive 10 ml of oral metoclopramide (10mg) + 5 ml of flavored water in total volume 15 ml
Treatment:
Drug: metoclopramide (10mg)
Group (E)
Active Comparator group
Description:
will be receive 10 ml of oral Erythromycin (400mg) + 5 ml of flavored water in total volume 15 ml
Treatment:
Drug: Erythromycin (400mg)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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