Effect of Intravenous Metochlopramide Prophylaxis on Gastric Volume

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.

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

Study Overview

• Status: Completed
• Conditions: Aspiration Prophylaxis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 111

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Assiut University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 38 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

pregnant females

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effect of S intravenous metoclopramide prophylaxis on gastric volume	antral cross section will be measured using ultrasound machine before and after metoclopramide injection	2 hours

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2021
• Primary Completion (Actual): October 30, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: September 3, 2020
• First Submitted That Met QC Criteria: October 23, 2020
• First Posted (Actual): October 30, 2020

Study Record Updates

• Last Update Posted (Actual): March 8, 2022
• Last Update Submitted That Met QC Criteria: February 20, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: ultrasound; metoclopramide; cesarean section; gastric volume
• Other Study ID Numbers: DASH1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: only the outcome of the study no personal identity will be revealed

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No