Ultrasound Assessment of Metoclopramide Effect on Gastric Volume in Cesarean Section

Aspiration Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04157998
• Other study ID #: 17300323
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: June 1, 2020

Study information

• Verified date: March 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Aspiration Pneumonia
• Pneumonia
• Pneumonia, Aspiration

Intervention

Drug:
• normal saline
intrvenous administration of 10ml normal saline preoperative
• Metoclopramide 10mg
intrvenous administration of 10mg metoclopramide diluted in 10ml normal saline preoperative

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (3)

Lead Sponsor	Collaborator
Assiut University	Esam Hamed, Wafaa Hamza

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ultrasound quantitative assessment of gastric antrum cross-sectional area	gastric 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.	10 hours
Primary	the gastric antrum cross-sectional area	based 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.	10 hours