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Aspiration VomitusEarly Phase 1NCT04290026

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

A Early Phase 1 study testing metoclopramide versus granisetron in people with Aspiration Vomitus, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Aspiration Vomitus
What is being tested?
metoclopramide versus granisetron
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteEgypt
Study dates
1 Apr 2021to 1 Apr 2022
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • women who have a history of :
  • diabetes mellitus
  • hypertension
  • preeclampsia
  • neurological and psychological disorders
  • renal or hepatic diseases
  • chronic Gerd
  • refusal to provide informed consent

Trial locations and contacts

1 site in 1 country.

Egypt1 site, 1 recruiting
  • Assiut university

    Asyut

    Assiut University, +20882411872, amgrants@yahoo.com

    Recruiting

Other trials in Egypt

About this study

Official title: 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

Read the 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.

Being tested
metoclopramide versus granisetron
Medical subject headings
Respiratory Aspiration of Gastric Contents

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • metoclopramide versus granisetronDrug

    ِِِِAssessment of the effect of metoclopramide versus granisetron on gastric volume in patients undergoing caesarean section by us

Study groups in NCT04290026
Study groupRoleWhat they receive
metoclopramide versus granisetronActive comparatorUltrasound assessment of the effect of metoclopramide versus granisetron on gastric volume in patients undergoing caesarean section: A randomized, double-blind, placebo-controlled study
Receives: Drug: metoclopramide versus granisetron

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 1. The size of the cross-sectional antral area

    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.

    Measured: Immediately after the procedure

Secondary outcomes (1)
  1. The incidence of post operative nausea or vomiting and the effects on the hemodynamic status

    Measured: 1day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2020
  2. Study start1 Apr 2021
  3. Primary completion31 Jan 2022 (estimated)
  4. Study completion1 Apr 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04290026
Sponsor's protocol ID
us, gastric volume
Status last verified
Jul 2021
First submitted
24 Feb 2020
Last updated
21 Jul 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing metoclopramide versus granisetron in people with Aspiration Vomitus, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mohamed Ahmed (0201060207238, mohamedelkhatib90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1. The size of the cross-sectional antral area (time frame: Immediately after the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.

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