Effect on Gastric Residual Volume

Sponsor

Cairo University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04682691

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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

Anticipated Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Jan 1, 2022

Anticipated Study Completion Date :

Feb 1, 2022

Arms and Interventions

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)

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

Primary Outcome Measures

Estimated Gastric volume [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

The duration for performing the ultrasound scanning [up to 2 hours]
minute

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)

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

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Cairo University.	Cairo		Egypt	11451

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Dec 24, 2020

Last Update Posted:

Dec 28, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Erythromycin

Erythromycin Estolate

Erythromycin Ethylsuccinate

Erythromycin stearate

Metoclopramide

Study Results

No Results Posted as of Dec 28, 2020