Ultrasound Assessment of Metoclopramide Effect on Gastric Volume in Cesarean Section

NCT04157998 | Unknown DMC

• 1 other identifier: 17300323
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

the risk of aspiration pneumonitis during cesarean sections has significantly decreased. Nevertheless, precaution against gastric aspiration is still vital in patients in whom regional anesthesia contraindicated or in whom general anesthesia has to be administered (for example; during emergency cesarean delivery). The administration of intravenous anesthetics reduces the level of consciousness of a patient that compromises the protective reflexes of the upper airways. Moreover, a high level of sedation also reduces the tone of the LES (lower oesophageal sphincter). Both these situations predispose the risk of aspiration pneumonia in patients awaiting surgical interventions in supine position under general anesthesia

Conditions

Aspiration Pneumonia

Outcome Measures

Primary Outcomes (2)

• ultrasound quantitative assessment of gastric antrum cross-sectional area

  gastric antrum cross-sectional area calculated as a function of the anteroposterior (APD) and craniocaudal diameter (CCD). Calculation of the cross-sectional area (CSA) conducted as a product of APD and CCD in square centimeters.

  10 hours

• the gastric antrum cross-sectional area

  based on three grading system which was as follows: G-0: Antrum was flat and empty in a supine and right lateral position * G-1: Antrum had fluid in the right lateral position but empty in the supine position * G-2: Antrum had fluid and food in both the supine and right lateral position.

  10 hours

Study Arms (2)

control

PLACEBO COMPARATOR

patient receive 10 ml normal saline intravenous

Drug: normal saline

metoclopramide group

ACTIVE COMPARATOR

patient receive 10 mg metoclopramide intravenously diluted in 10 mL saline 0.9%. intravenous

Drug: Metoclopramide 10mg

Interventions

normal saline DRUG

intrvenous administration of 10ml normal saline preoperative

control

Metoclopramide 10mg DRUG

intrvenous administration of 10mg metoclopramide diluted in 10ml normal saline preoperative

metoclopramide group

Eligibility Criteria

• Age: 20 Years - 38 Years
• Gender Eligibility Details: pregnant female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• pregnant women
• age range between 20 to 38 years
• provided informed consent to participate.

You may not qualify if:

• patient refusal
• associated co-morbidity as diabetes mllitus, hypertension, preeclampsia, renal or hepatic diseases
• neurological and psychological disorders, ,
• chronic gastroesophageal reflux diseases

Sponsors & Collaborators

• Assiut University: lead
• Esam Hamed: collaborator
• Wafaa Hamza: collaborator

Study Sites (1)

Assiut university

Asyut, 71515, Egypt

RECRUITING

MeSH Terms

Conditions

Pneumonia, Aspiration

Interventions

Saline Solution; Metoclopramide

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

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

Study Record Dates

• First Submitted: November 2, 2019
• First Posted: November 8, 2019
• Study Start: November 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: June 1, 2020
• Last Updated: March 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)