Ultrasound Assessment of Metoclopramide Effect on Gastric Volume in Cesarean Section

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-06-01

Brief Summary

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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

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Detailed Description

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Since regional anesthesia has largely replaced general anesthesia, 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 .

The risk of aspiration increases in outpatients if the volume of the gastric contents increases beyond 25 ml, and its pH falls below 2.5. However, the risk of aspiration significantly decreases in "fasted" outpatients. Since most patients awaiting elective surgery remains fasted, routine prophylaxis for preventing aspiration pneumonitis not recommended anymore. Studies suggest that metoclopramide, in combination with H2-receptor antagonists (such as cimetidine), significantly reduces the risk of postoperative emesis and aspiration pneumonitis. However, the time available for administering oral prophylaxis with such anti-emetic and anti-histaminic is too short for these medications to be effective

Conditions

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Aspiration Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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control

patient receive 10 ml normal saline intravenous

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

intrvenous administration of 10ml normal saline preoperative

metoclopramide group

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

intravenous

Group Type ACTIVE_COMPARATOR

Metoclopramide 10mg

Intervention Type DRUG

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

Interventions

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normal saline

intrvenous administration of 10ml normal saline preoperative

Intervention Type DRUG

Metoclopramide 10mg

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No