Effect of Intravenous Metochlopramide Prophylaxis on Gastric Volume

NCT ID: NCT04609124

Last Updated: 2022-03-08

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

111 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-24

Study Completion Date

2021-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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) .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aspiration Prophylaxis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group:

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

Abdominal ultrasound evaluation of antral area

Intervention Type DIAGNOSTIC_TEST

ultrasound assessment of antral cross sectional area

Control group:

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

Abdominal ultrasound evaluation of antral area

Intervention Type DIAGNOSTIC_TEST

ultrasound assessment of antral cross sectional area

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Abdominal ultrasound evaluation of antral area

ultrasound assessment of antral cross sectional area

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Nausea and vomiting episodes

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

22 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Esam Hamed

Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Assiut University Hospitals

Asyut, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DASH1001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.