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Effect of Metoclopramide Versus Erythromycin on on Gastric Residual Volume

Not Applicable
Completed
Conditions
Gastric Residual Volume
Interventions
Dietary Supplement: naturally flavored water
Registration Number
NCT04682691
Lead Sponsor
Cairo University
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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
50
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

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group (C)naturally flavored waterwill be receive flavored water in total volume 15 ml
Group (M)metoclopramide (10mg)will be receive 10 ml of oral metoclopramide (10mg) + 5 ml of flavored water in total volume 15 ml
Group (E)Erythromycin (400mg)will be receive 10 ml of oral Erythromycin (400mg) + 5 ml of flavored water in total volume 15 ml
Primary Outcome Measures
NameTimeMethod
Estimated Gastric volumeUP TO 6 HOURE

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

Secondary Outcome Measures
NameTimeMethod
quantitative gastric contentsup to 24 hours

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

low-risk stomach six hours after drug administrationup to 6 hours

number of patient and %

Perlas grading systemUP 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

Evaluation of the risk of aspirationUP TO 24 HOURE

residual gastric volume \< 1.5 mL/kg

Trial Locations

Locations (1)

Faculty of Medicine, Cairo University.

🇪🇬

Cairo, Egypt

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