Aspiration ProphylaxisNCT04609124
Effect of Intravenous Metochlopramide Prophylaxis on Gastric Volume
An observational study of Aspiration Prophylaxis, run by Assiut University at 1 site in Egypt.
Trial summary
Gastric fluid volume and pH in patients undergoing cesarean section are essential considerations for general anesthesia (GA). Increased gastric volume and low pH of gastric contents could predispose the risk of aspiration pneumonitis. Read more about this study
- Who is it for?
- Ages 22 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aspiration Prophylaxis
- What is being tested?
- Abdominal ultrasound evaluation of antral area
- Type of treatment
- Injection or infusion
- How many people
- 111 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Oct 2021to 30 Dec 2021
- Phase
- Observational
- 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 22 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: pregnant females
Who may be able to join
- pregnant women belonging to the age range between 22 to 38 years and who provided informed consent to participate.
Who cannot join
- a neurological and psychological disorders
- renal or hepatic diseases
- chronic gastroesophageal reflux diseases
- refusal to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: the Effect of Intravenous Metochlopramide Prophylaxis on Gastric Volume and Antral Cross Sectional Area in Patients Awaiting for Caesarean Section :a Randomized Double Blind Study.
Gastric fluid volume and pH in patients undergoing cesarean section are essential considerations for general anesthesia (GA). Increased gastric volume and low pH of gastric contents could predispose the risk of aspiration pneumonitis. The present study explored the research question "whether prophylaxis with intravenous metoclopramide significantly reduces gastric volume and antral cross-sectional area in patients awaiting cesarean section under GA
Read the detailed description
Since regional anaesthesia has largely replaced general anaesthesia, the risk of aspiration pneumonitis during caesarean sections has significantly decreased. Nevertheless, prophylaxis against gastric aspiration is still important in patients in whom regional anaesthesia is contraindicated or in whom general anaesthesia has to be administered (for example; during emergency caesarean delivery). The administration of intravenous anaesthetics 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 anaesthesia.
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 is not recommended anymore.
the administration of intravenous metoclopramide and cimetidine across patients (n=20) awaiting laparoscopic gynaecological surgery significantly increased the pH of the gastric contents in the intervention group compared to their control counterparts (6.1 versus 2.7, p<0.05). The mean aspirated volumes were also significantly lower in the intervention group compared to their age-matched controls (6.9ml versus 15.3ml, p<0.05). Hong (2006) further showed that the percentage of individuals with high-risk gastric volume (>25 ml) and low pH (<2.5) was higher in individuals who did not receive intravenous metoclopramide and cimetidine prior to surgery compared to their counterparts who received such interventions (20% versus 5%, p<0.05) .
- Conditions
- Aspiration Prophylaxis
- Being tested
- Abdominal ultrasound evaluation of antral area
- Keywords
- metoclopramide, cesarean section, ultrasound, gastric volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal ultrasound evaluation of antral areaDiagnostic test
Also called Nausea and vomiting episodes
ultrasound assessment of antral cross sectional area
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: | Patients (n=35) fasting for 8 hours and received 10 mg metoclopramide intravenously diluted in 10 mL saline 0.9%. Receives: Diagnostic Test: Abdominal ultrasound evaluation of antral area | |
| Control group: | Patients (n=35) fasting for 8 hours and received intravenous 10 mL saline 0.9% as placebo Receives: Diagnostic Test: Abdominal ultrasound evaluation of antral area |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of S intravenous metoclopramide prophylaxis on gastric volume
antral cross section will be measured using ultrasound machine before and after metoclopramide injection
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start24 Oct 2021
- Primary completion30 Oct 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aspiration ProphylaxisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esam Hamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609124
- Sponsor's protocol ID
- DASH1001
- Status last verified
- Feb 2022
- First submitted
- 3 Sep 2020
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: only the outcome of the study no personal identity will be revealed
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Intravenous Metochlopramide Prophylaxis on Gastric Volume and Antral Cross Sectional Area in Patients Awaiting for Caesarean Section :a Randomized Double Blind Study.
- ClinicalTrials.gov ID
- NCT04609124
- Acronym / sponsor ID
- DASH1001
- Conditions
- Aspiration Prophylaxis
- Keywords
- metoclopramide, cesarean section, ultrasound, gastric volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 24 Oct 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 30 Oct 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.
Gastric fluid volume and pH in patients undergoing cesarean section are essential considerations for general anesthesia (GA). Increased gastric volume and low pH of gastric contents could predispose the risk of aspiration pneumonitis. The present study explored the research question "whether prophylaxis with intravenous metoclopramide significantly reduces gastric volume and antral cross-sectional area in patients awaiting cesarean section under GA
Detailed description
Since regional anaesthesia has largely replaced general anaesthesia, the risk of aspiration pneumonitis during caesarean sections has significantly decreased. Nevertheless, prophylaxis against gastric aspiration is still important in patients in whom regional anaesthesia is contraindicated or in whom general anaesthesia has to be administered (for example; during emergency caesarean delivery). The administration of intravenous anaesthetics 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 anaesthesia.
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 is not recommended anymore.
the administration of intravenous metoclopramide and cimetidine across patients (n=20) awaiting laparoscopic gynaecological surgery significantly increased the pH of the gastric contents in the intervention group compared to their control counterparts (6.1 versus 2.7, p<0.05). The mean aspirated volumes were also significantly lower in the intervention group compared to their age-matched controls (6.9ml versus 15.3ml, p<0.05). Hong (2006) further showed that the percentage of individuals with high-risk gastric volume (>25 ml) and low pH (<2.5) was higher in individuals who did not receive intravenous metoclopramide and cimetidine prior to surgery compared to their counterparts who received such interventions (20% versus 5%, p<0.05) .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group: | – | Diagnostic Test: Abdominal ultrasound evaluation of antral areaPatients (n=35) fasting for 8 hours and received 10 mg metoclopramide intravenously diluted in 10 mL saline 0.9%. |
| Control group: | – | Diagnostic Test: Abdominal ultrasound evaluation of antral areaPatients (n=35) fasting for 8 hours and received intravenous 10 mL saline 0.9% as placebo |
Who may qualify
- Ages
- 22 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- pregnant females
Key inclusion criteria (1 listed)
- pregnant women belonging to the age range between 22 to 38 years and who provided informed consent to participate.
Key exclusion criteria (4 listed)
- a neurological and psychological disorders
- renal or hepatic diseases
- chronic gastroesophageal reflux diseases
- refusal to 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 |
|---|---|---|
| Abdominal ultrasound evaluation of antral areaAlso: Nausea and vomiting episodesultrasound assessment of antral cross sectional area | Diagnostic test | Control group:, Intervention group: |
Primary outcome
effect of S intravenous metoclopramide prophylaxis on gastric volume
Time frame: 2 hours
antral cross section will be measured using ultrasound machine before and after metoclopramide injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Individual participant dataSharing planned: No. only the outcome of the study no personal identity will be revealed
Related trials for Aspiration Prophylaxis
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aspiration Prophylaxis, 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 8 Mar 2022. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect of S intravenous metoclopramide prophylaxis on gastric volume (time frame: 2 hours). 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 8 Mar 2022.