NCT04682691

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 24, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2024

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2024

Completed
Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

2.9 years

First QC Date

December 19, 2020

Last Update Submit

January 10, 2025

Conditions

Gastric Residual Volume

Keywords

ErythromycinGastric EmptyingMetoclopramideUltrasonography

Outcome Measures

Primary Outcomes (1)

  • Estimated Gastric volume

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

    UP TO 6 HOURE

Secondary Outcomes (4)

  • low-risk stomach six hours after drug administration

    up to 6 hours

  • Perlas grading system

    UP TO 24 HOURE

  • Evaluation of the risk of aspiration

    UP TO 24 HOURE

  • quantitative gastric contents

    up to 24 hours

Study Arms (3)

Group (C)

SHAM COMPARATOR

will be receive flavored water in total volume 15 ml

Dietary Supplement: naturally flavored water

Group (M)

ACTIVE COMPARATOR

will be receive 10 ml of oral metoclopramide (10mg) + 5 ml of flavored water in total volume 15 ml

Drug: metoclopramide (10mg)

Group (E)

ACTIVE COMPARATOR

will be receive 10 ml of oral Erythromycin (400mg) + 5 ml of flavored water in total volume 15 ml

Drug: Erythromycin (400mg)

Interventions

Erythromycin (400mg)DRUG

oral Erythromycin (400mg)

Group (E)
metoclopramide (10mg)DRUG

oral metoclopramide (10mg)

Group (M)
naturally flavored waterDIETARY_SUPPLEMENT

naturally flavored water

Group (C)

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsonly pregnancy women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Cairo University.

Cairo, Egypt, 11451, Egypt

Location

MeSH Terms

Interventions

ErythromycinMetoclopramide

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic ChemicalsBenzamidesAmidespara-AminobenzoatesAminobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsChlorobenzoatesHydroxybenzoate EthersHydroxybenzoatesHydroxy AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenyl EthersPhenols

Study Officials

  • Amr wahdan, MD

    Cairo university , Cairo, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Anesthesia, Pain management and Surgical ICU

Study Record Dates

First Submitted

December 19, 2020

First Posted

December 24, 2020

Study Start

March 1, 2021

Primary Completion

February 5, 2024

Study Completion

February 22, 2024

Last Updated

January 14, 2025

Record last verified: 2025-01

Locations

EG(1)