Granisetron Versus Metoclopramide Effects on Gastric Volume by Sonographic Assessment on Patients Undergoing Caesarean Section.

July 19, 2021 updated by: Mohamed Ahmed, Assiut University

Ultrasound Assessment of the Effect of Metoclopramide Versus Granisetron on Gastric Volume in Patients Undergoing Caesarean Section

Ultrasound assessment of the effect of metoclopramide versus granisetron on gastric volume in patients undergoing caesarean section study

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Nausea and vomiting in the perioperative period are common sequelae during abdominal operations, with variable rates up to 80%, as reported in the literature. Perioperative nausea and vomiting associated with pregnancy originate from multiple factors. Pregnancy hormones induced lowering of the lower oesophageal sphincter tone, elevated gastric pressure by the effect of gravid uterus, hypotension, manipulation of the uterus during the operation that leads to visceral stimulation, and the use of opioids; which represent some of the proposed causative factors .

There is a lack of cost-effectiveness and consensus about prophylactic antiemetic use before abdominal surgeries. However, there is enough data reported in the literature that suggests the prophylactic use of antiemetic therapy for patients undergoing cesarean section (CS) under either general or regional anesthesia and as rescue medication for the treatment of episodes of intraoperative and postoperative nausea and vomiting.

Metoclopramide studied intensively as one of the best premedications in patients undergoing abdominal surgeries, especially in the obstetric population. It has a favorable effect on reducing the gastric fluid volume during the operation and consequently decreasing the incidence of aspiration pneumonia .

Granisetron is a selective 5-HT3 receptor antagonist with little or no affinity for other serotonin receptors is classified as drug group B in pregnant patients and approved by the FDA (Food and Drug Administration) for the treatment of post-operative nausea and vomiting in adults . 5-HT3 receptor antagonists exert appropriate clinical efficacy and low incidence of adverse drug reactions. In comparison with ondansetron, granisetron is a more potent antagonist with a longer duration of action .

Different methods such as paracetamol absorption, polyethylene glycol dilution (PEG), and electric impedance tomography (EIT) suggested as methods for visualizing the structure, volume, and time to the emptying of the stomach. Gastric scintigraphy remains the gold standard for such detections . However, scintigraphy is discouraged in routine clinical settings and pregnant patients owing to the risk of radiation exposure, low cost-effectiveness, and intricate instrumental setups.

Gastric ultrasonography (GUS) has emerged as an accessible, cost-effective, safe, and portable diagnostic modality for visualizing the gastric morphology. Different studies suggest that gastric contents and volume measured through GUS significantly correlated to the cross-sectional antral area. As a result, the reliability and reproducibility of bedside GUS cannot be challenged.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Assiut, Egypt
        • Recruiting
        • Assiut University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant women
  • Age :18-45
  • Informed consent

Exclusion Criteria:

  1. women who have a history of :

    • diabetes mellitus
    • hypertension
    • preeclampsia
    • neurological and psychological disorders
    • renal or hepatic diseases
    • chronic Gerd
  2. refusal to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: metoclopramide versus granisetron
Ultrasound assessment of the effect of metoclopramide versus granisetron on gastric volume in patients undergoing caesarean section: A randomized, double-blind, placebo-controlled study
Drug: metoclopramide versus granisetron
ِِِِAssessment of the effect of metoclopramide versus granisetron on gastric volume in patients undergoing caesarean section by us

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. The size of the cross-sectional antral area
Time Frame: Immediately after the procedure
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.
Immediately after the procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
The incidence of post operative nausea or vomiting and the effects on the hemodynamic status
Time Frame: 1day
1day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: saeid metwally, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Anticipated)

January 31, 2022

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

February 24, 2020

First Submitted That Met QC Criteria

February 26, 2020

First Posted (Actual)

February 28, 2020

Study Record Updates

Last Update Posted (Actual)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 19, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • us, gastric volume

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Time Frame

3 years

IPD Sharing Access Criteria

age, sex ,clinical diagnosis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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