- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04157998
Ultrasound Assessment of Metoclopramide Effect on Gastric Volume in Cesarean Section
Ultrasound Assessment of Metoclopramide Effect on Gastric Volume in Patients Undergoing Cesarean Section: A Randomized, Double-blind, Cross-sectional Study"
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Assiut, Egypt, 71515
- Recruiting
- Assiut University
-
Contact:
- rasha hamed, MD
- Phone Number: 0882413201
- Email: rashaahmed11@@yahoo.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: control
patient receive 10 ml normal saline intravenous
|
intrvenous administration of 10ml normal saline preoperative
|
Active Comparator: metoclopramide group
patient receive 10 mg metoclopramide intravenously diluted in 10 mL saline 0.9%. intravenous |
intrvenous administration of 10mg metoclopramide diluted in 10ml normal saline preoperative
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
10 hours
|
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
|
10 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia
- Lung Diseases
- Pneumonia, Aspiration
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Dopamine Agents
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Metoclopramide
Other Study ID Numbers
- 17300323
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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