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Ultrasound Assessment of Metoclopramide Effect on Gastric Volume in Cesarean Section

Primary Purpose

Aspiration Pneumonia

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
normal saline
Metoclopramide 10mg
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aspiration Pneumonia

Eligibility Criteria

20 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Assiut universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

control

metoclopramide group

Arm Description

patient receive 10 ml normal saline intravenous

patient receive 10 mg metoclopramide intravenously diluted in 10 mL saline 0.9%. intravenous

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 2, 2019
Last Updated
March 26, 2020
Sponsor
Assiut University
Collaborators
Esam Hamed, Wafaa Hamza
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1. Study Identification

Unique Protocol Identification Number
NCT04157998
Brief Title
Ultrasound Assessment of Metoclopramide Effect on Gastric Volume in Cesarean Section
Official Title
Ultrasound Assessment of Metoclopramide Effect on Gastric Volume in Patients Undergoing Cesarean Section: A Randomized, Double-blind, Cross-sectional Study"
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
May 1, 2020 (Anticipated)
Study Completion Date
June 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
Collaborators
Esam Hamed, Wafaa Hamza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aspiration Pneumonia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Placebo Comparator
Arm Description
patient receive 10 ml normal saline intravenous
Arm Title
metoclopramide group
Arm Type
Active Comparator
Arm Description
patient receive 10 mg metoclopramide intravenously diluted in 10 mL saline 0.9%. intravenous
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
intrvenous administration of 10ml normal saline preoperative
Intervention Type
Drug
Intervention Name(s)
Metoclopramide 10mg
Intervention Description
intrvenous administration of 10mg metoclopramide diluted in 10ml normal saline preoperative
Primary Outcome Measure Information:
Title
ultrasound quantitative assessment of gastric antrum cross-sectional area
Description
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.
Time Frame
10 hours
Title
the gastric antrum cross-sectional area
Description
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.
Time Frame
10 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Assiut university
City
Assiut
ZIP/Postal Code
71515
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
rasha hamed, MD
Phone
0882413201
Email
rashaahmed11@@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Ultrasound Assessment of Metoclopramide Effect on Gastric Volume in Cesarean Section

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