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CompletedNCT04609124Updated Mar 8, 2022

Effect of Intravenous Metochlopramide Prophylaxis on Gastric Volume

An observational study in Aspiration Prophylaxis, sponsored by Assiut University. Completed at 1 site in Egypt. Open to female participants aged 22 Years to 38 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-08.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
111
Ages
22 Years to 38 Years
Sex
Female
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Study summary

Gastric fluid volume and pH in patients undergoing cesarean section are essential considerations for general anesthesia (GA). Increased gastric volume and low pH of gastric contents could predispose the risk of aspiration pneumonitis. The present study explored the research question "whether prophylaxis with intravenous metoclopramide significantly reduces gastric volume and antral cross-sectional area in patients awaiting cesarean section under GA

Read the detailed description

Since regional anaesthesia has largely replaced general anaesthesia, the risk of aspiration pneumonitis during caesarean sections has significantly decreased. Nevertheless, prophylaxis against gastric aspiration is still important in patients in whom regional anaesthesia is contraindicated or in whom general anaesthesia has to be administered (for example; during emergency caesarean delivery). The administration of intravenous anaesthetics 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 anaesthesia.

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 is not recommended anymore.

the administration of intravenous metoclopramide and cimetidine across patients (n=20) awaiting laparoscopic gynaecological surgery significantly increased the pH of the gastric contents in the intervention group compared to their control counterparts (6.1 versus 2.7, p\<0.05). The mean aspirated volumes were also significantly lower in the intervention group compared to their age-matched controls (6.9ml versus 15.3ml, p\<0.05). Hong (2006) further showed that the percentage of individuals with high-risk gastric volume (>25 ml) and low pH (\<2.5) was higher in individuals who did not receive intravenous metoclopramide and cimetidine prior to surgery compared to their counterparts who received such interventions (20% versus 5%, p\<0.05) .

02

Conditions studied

  • Aspiration Prophylaxis

Keywords

  • metoclopramide
  • cesarean section
  • ultrasound
  • gastric volume
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In context

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
22 Years to 38 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

pregnant females

Inclusion criteria

  • pregnant women belonging to the age range between 22 to 38 years and who provided informed consent to participate.

Exclusion criteria

Exclusion Criteria:

  • a neurological and psychological disorders
  • renal or hepatic diseases
  • chronic gastroesophageal reflux diseases
  • refusal to consent
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
111 participants (actual)
Patient registry
No

Groups and cohorts

  • Intervention group:

    Patients (n=35) fasting for 8 hours and received 10 mg metoclopramide intravenously diluted in 10 mL saline 0.9%.

    Diagnostic Test: Abdominal ultrasound evaluation of antral area

  • Control group:

    Patients (n=35) fasting for 8 hours and received intravenous 10 mL saline 0.9% as placebo

    Diagnostic Test: Abdominal ultrasound evaluation of antral area

Interventions

  • Diagnostic testAbdominal ultrasound evaluation of antral area

    ultrasound assessment of antral cross sectional area

    Also known as: Nausea and vomiting episodes

06

What researchers measure

Primary outcomes

  1. effect of S intravenous metoclopramide prophylaxis on gastric volume

    antral cross section will be measured using ultrasound machine before and after metoclopramide injection

    Time frame: 2 hours

07

Study locations

1 site
  • Assiut University Hospitals
    Assiut, 71515, Egypt
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References and documents

Individual participant data

Plan to share: No — only the outcome of the study no personal identity will be revealed

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04609124
Lead sponsor
Assiut University
Responsible party
Esam Hamed (Consultant, Assiut University) — Principal investigator
First posted
Oct 30, 2020
Start date
Oct 24, 2021
Primary completion
Oct 30, 2021
Completion
Dec 30, 2021
Last update
Mar 8, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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