Clincosm LogoSign in Get a demo

Effect of Intravenous Metochlopramide Prophylaxis on Gastric Volume

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT04609124
Collaborator
(none)
111
Enrollment
1
Location
2.2
Actual Duration (Months)
50.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Abdominal ultrasound evaluation of antral area

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) .

Study Design

Study Type:
Observational
Actual Enrollment :
111 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
the Effect of Intravenous Metochlopramide Prophylaxis on Gastric Volume and Antral Cross Sectional Area in Patients Awaiting for Caesarean Section :a Randomized Double Blind Study.
Actual Study Start Date :
Oct 24, 2021
Actual Primary Completion Date :
Oct 30, 2021
Actual Study Completion Date :
Dec 30, 2021

Arms and Interventions

Arm Intervention/Treatment
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
ultrasound assessment of antral cross sectional area
Other Names:
  • Nausea and vomiting episodes

    		•
    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
    ultrasound assessment of antral cross sectional area
    Other Names:
  • Nausea and vomiting episodes

    		•

    Outcome Measures

    Primary Outcome Measures

    1. effect of S intravenous metoclopramide prophylaxis on gastric volume [2 hours]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years to 38 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • pregnant women belonging to the age range between 22 to 38 years and who provided informed consent to participate.
    Exclusion Criteria:

    • a neurological and psychological disorders

    • renal or hepatic diseases

    • chronic gastroesophageal reflux diseases

    • refusal to consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut University Hospitals Assiut Egypt 71515

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Esam Hamed, Consultant, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04609124
    Other Study ID Numbers:
    • DASH1001
    First Posted:
    Oct 30, 2020
    Last Update Posted:
    Mar 8, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Esam Hamed, Consultant, Assiut University
    metoclopramide
    cesarean section
    ultrasound
    gastric volume

    Study Results

    No Results Posted as of Mar 8, 2022