Effect on Gastric Residual Volume

Overview

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

Full Title of Study: “Comparison of the Effect of Metoclopramide Versus Erythromycin on Gastric Residual Volume”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 1, 2022

Interventions

  • Drug: Erythromycin (400mg)
    • parturients will receive oral Erythromycin (400mg)
  • Drug: metoclopramide (10mg)
    • will be receive oral metoclopramide (10mg)
  • Dietary Supplement: naturally flavored water
    • will be receive naturally flavored water

Arms, Groups and Cohorts

  • Sham Comparator: Group (C)
    • who will receive flavored water in total volume 15 ml at two hours preoperative.
  • Active Comparator: Group (M)
    • will be receive 10 ml of oral metoclopramide (10mg)
  • Active Comparator: Group (E)
    • will receive 10 ml of oral Erythromycin (400mg)

Clinical Trial Outcome Measures

Primary Measures

  • Estimated Gastric volume
    • Time Frame: UP TO 24 HOURE
    • (mL) based on the antral CSA in the RLD (CSARLD) by gastric ultrasonic after administration of the study drug.

Secondary Measures

  • The duration for performing the ultrasound scanning
    • Time Frame: up to 2 hours
    • minute

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Amr Samir Wahdan, Lecturer of Anesthesia, Pain management and Surgical ICU – Cairo University

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