Clinical trial NCT04682691: Effect of Metoclopramide Versus Erythromycin on on Gastric Residual Volume
Official title: Comparison of the Effect of Metoclopramide Versus Erythromycin on Gastric Residual Volume
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Residual Volume
Keywords: Erythromycin
Gastric Emptying
Metoclopramide
Ultrasonography
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility 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)

  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

Primary outcomes:
measure: Estimated Gastric volume
timeFrame: UP TO 6 HOURE
Secondary outcomes:
measure: low-risk stomach six hours after drug administration
timeFrame: up to 6 hours
measure: Perlas grading system
timeFrame: UP TO 24 HOURE
measure: Evaluation of the risk of aspiration
timeFrame: UP TO 24 HOURE
measure: quantitative gastric contents
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Cairo University.
Study officials:
affiliation: Cairo university , Cairo, Egypt
name: Amr wahdan, MD
role: PRINCIPAL_INVESTIGATOR
References: