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.
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
- Recruiting
Assiut university
Asyut
Assiut University, +20882411872, amgrants@yahoo.com
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.
- Conditions
- Aspiration Vomitus
- 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 group | Role | What they receive |
|---|---|---|
| metoclopramide versus granisetron | Active comparator | Ultrasound 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. 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)
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.
- First posted28 Feb 2020
- Study start1 Apr 2021
- Primary completion31 Jan 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aspiration VomitusStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed, Assiut University
- Investigators
- saeid metwally, Study director, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of the Effect of Metoclopramide Versus Granisetron on Gastric Volume in Patients Undergoing Caesarean Section
- ClinicalTrials.gov ID
- NCT04290026
- Acronym / sponsor ID
- us, gastric volume
- Conditions
- Aspiration Vomitus
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 28 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ultrasound assessment of the effect of metoclopramide versus granisetron on gastric volume in patients undergoing caesarean section study
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| metoclopramide versus granisetron | Active comparator | Drug: metoclopramide versus granisetronUltrasound assessment of the effect of metoclopramide versus granisetron on gastric volume in patients undergoing caesarean section: A randomized, double-blind, placebo-controlled study |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women
- Age :18-45
- Informed consent
Key exclusion criteria (8 listed)
- women who have a history of :
- refusal to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metoclopramide versus granisetronِِِِAssessment of the effect of metoclopramide versus granisetron on gastric volume in patients undergoing caesarean section by us | Drug | metoclopramide versus granisetron |
Primary outcome
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.
1 secondary outcome
The incidence of post operative nausea or vomiting and the effects on the hemodynamic status
Time frame: 1day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Individual participant dataSharing planned: Yes
Related trials for Aspiration Vomitus
Enrolling by invitationObservational study
Effect of Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) on Gastric Emptying
Gastric Emptying, Glucagon-Like Peptide-1 Receptor Agonists
Recruiting
Effect of Fasting Recommendations Among Patients Using GLP-1 Receptor Agonists
Residual Gastric Contents, Pulmonary Aspiration of Gastric Contents
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
saeid metwally study director
Assiut University
1 site in 1 country: see every site and its status.
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.