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Effect on Gastric Residual Volume

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04682691
Recruitment Status : Enrolling by invitation
First Posted : December 24, 2020
Last Update Posted : December 28, 2020
Sponsor:
Information provided by (Responsible Party):
Amr Samir Wahdan, Cairo University

Study Description
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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

Condition or disease Intervention/treatment Phase
Gastric Residual Volume Drug: Erythromycin (400mg) Drug: metoclopramide (10mg) Dietary Supplement: naturally flavored water Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Effect of Metoclopramide Versus Erythromycin on Gastric Residual Volume
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : February 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Sham Comparator: Group (C)
who will receive flavored water in total volume 15 ml at two hours preoperative.
 Dietary Supplement: naturally flavored water
will be receive naturally flavored water
Active Comparator: Group (M)
will be receive 10 ml of oral metoclopramide (10mg)
 Drug: metoclopramide (10mg)
will be receive oral metoclopramide (10mg)
Active Comparator: Group (E)
will receive 10 ml of oral Erythromycin (400mg)
 Drug: Erythromycin (400mg)
parturients will receive oral Erythromycin (400mg)


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. The duration for performing the ultrasound scanning [ Time Frame: up to 2 hours ]
    minute


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04682691


Locations
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Egypt
Faculty of Medicine, Cairo University.
Cairo, Egypt, 11451
Sponsors and Collaborators
Cairo University
More Information
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Responsible Party: Amr Samir Wahdan, Lecturer of Anesthesia, Pain management and Surgical ICU, Cairo University
ClinicalTrials.gov Identifier: NCT04682691    
Other Study ID Numbers: MS-381-2020
First Posted: December 24, 2020    Key Record Dates
Last Update Posted: December 28, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Metoclopramide
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
 Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors