Ultrasound Assessment of Metoclopramide Effect on Gastric Volume in Cesarean Section

Assiut University

Status: Unknown

Conditions: Aspiration Pneumonia

Treatments: Drug: Metoclopramide 10mg; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04157998

17300323

Details and patient eligibility

About

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

Full description

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

Enrollment: 60 estimated patients

Sex: Female

Ages: 20 to 38 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

control

Placebo Comparator group

Description:

patient receive 10 ml normal saline intravenous

Treatment:

Drug: normal saline

metoclopramide group

Active Comparator group

Description:

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

Treatment:

Drug: Metoclopramide 10mg