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Ultrasound Assessment of Metoclopramide Effect on Gastric Volume in Cesarean Section

Ultrasound Assessment of Metoclopramide Effect on Gastric Volume in Patients Undergoing Cesarean Section: A Randomized, Double-blind, Cross-sectional Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04157998
Enrollment
60
Registered
2019-11-08
Start date
2019-11-01
Completion date
2020-06-01
Last updated
2020-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aspiration Pneumonia

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

Detailed 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

Interventions

DRUGnormal saline

intrvenous administration of 10ml normal saline preoperative

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

Sponsors

Esam Hamed
CollaboratorUNKNOWN
Wafaa Hamza
CollaboratorUNKNOWN
Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 38 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
ultrasound quantitative assessment of gastric antrum cross-sectional area10 hoursgastric 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.
the gastric antrum cross-sectional area10 hoursbased 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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026