Ultrasound Assessment of Metoclopramide Effect on Gastric Volume in Cesarean Section

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 1, 2020

Detailed 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

Interventions

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

Arms, Groups and Cohorts

  • Placebo Comparator: control
    • patient receive 10 ml normal saline intravenous
  • Active Comparator: metoclopramide group
    • patient receive 10 mg metoclopramide intravenously diluted in 10 mL saline 0.9%. intravenous

Clinical Trial Outcome Measures

Primary Measures

  • ultrasound quantitative assessment of gastric antrum cross-sectional area
    • Time Frame: 10 hours
    • 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.
  • the gastric antrum cross-sectional area
    • Time Frame: 10 hours
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Female

pregnant female

Minimum Age: 20 Years

Maximum Age: 38 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assiut University
  • Collaborator
    • Esam Hamed
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rasha Hamed, lecturer – Assiut University

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