Gastric Residual VolumeNCT07519447
Gastric Residual Volume and Aspiration Risk Following Intravenous Metoclopramide in Fasted Diabetic Patients Undergoing Elective Surgery
An observational study of Gastric Residual Volume and Aspiration Risk, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This study aimed to evaluate the effect of metoclopramide on preoperative gastric emptying in diabetic patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastric Residual Volume, Aspiration Risk, Metoclopramide
- What is being tested?
- Metoclopramide
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 1 Sep 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study was carried out on 60 patients undergoing elective surgery admitted to Kafr- Elsheikh University Hospitals over a period of 6 months starting from approval of the Medical Sciences Ethics Committee of Kafr- Elsheikh Faculty of Medicine.
Who may be able to join
- Age from 18 to 65 years old.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Underwent elective surgery.
Who cannot join
- Patients taking drugs that affect gastric motility.
- Patients with renal failure.
- Hypothyroidism.
- Obesity [body mass index (BMI) > 30kg/m2].
- Connective tissue disorders.
- History of gastrointestinal surgery.
- Those with steroid-induced hyperglycemia.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasonographic Assessment of Preoperative Gastric Residual Volume and Aspiration Risk Following Intravenous Metoclopramide in Fasted Diabetic Patients Undergoing Elective Surgery Under General Anesthesia: A Prospective Non-Randomized Controlled Comparative Study
This study aimed to evaluate the effect of metoclopramide on preoperative gastric emptying in diabetic patients.
Read the detailed description
Perioperative aspiration of gastric contents is a rare but serious complication of anesthesia. Aspiration pneumonia is associated with significant morbidity, including prolonged mechanical ventilation, and carries a risk of mortality as great as 5%.
Point-of-care (POC) gastric ultrasound has gained popularity in recent times. It has been adapted in the field of anesthesiology gradually to make the clinical decision before anesthetizing patients where the fasting status is uncertain and in emergency patients where surgery is mandated.
Metoclopramide, a medication used for diabetic gastroparesis, is a cholinergic agent that acts by increasing the release of acetylcholine at the neuromuscular junction within the gastric wall. Further, metoclopramide has antidopaminergic properties that inhibit dopamine-induced gastric smooth muscle relaxation, and it also penetrates the blood-brain barrier and binds to medullary chemoreceptors.
- Conditions
- Gastric Residual Volume, Aspiration Risk, Metoclopramide, Fasted Diabetic Patients, Elective Surgery
- Being tested
- Metoclopramide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetoclopramideDrug
Diabetic patients received a single IV dose of metoclopramide 10 mg (2 mL) administered 30-60 minutes prior to POC gastric ultrasound assessment, to allow for peak prokinetic effect.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Diabetic patients received a single IV dose of metoclopramide 10 mg (2 mL) administered 30-60 minutes prior to POC gastric ultrasound assessment, to allow for peak prokinetic effect. Receives: Drug: Metoclopramide | |
| Group II | Diabetic patients who did not receive metoclopramide or any other prokinetic agent preoperatively. | |
| Group III | Non-diabetic patients who did not receive metoclopramide, serving as a healthy reference group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antral cross-sectional area
Antral cross-sectional area (CSA) was measured by Point-of-Care (POC) ultrasound (cm²). Antral CSA was calculated using the standard ellipse formula:
Antral CSA (cm²) = π/4 × antero-posterior (AP) (cm) × cranio-caudal (CC) (cm)
Measured: 30 minutes after drug administration
Secondary outcomes (3)
Gastric volume
Gastric volume (GV) was estimated using the validated formula described by Perlas et al.:
GV (mL) = 27.0 + 14.6 × right lateral decubitus (RLD)-cross-sectional area (CSA)- 1.28 × Age
Measured: 30 minutes after drug administration
Antral gastric grade
Qualitative grading of gastric content was performed as follows, using the validated Perlas classification: Grade 0 - empty antrum in both semi-sitting (SS) and right lateral decubitus (RLD) positions (estimated GRV ≤0 mL, minimal aspiration risk); Grade 1 - fluid visible in RLD position only [estimated gastric residual volume (GRV) approximately 100-300 mL, low-to-intermediate risk]; Grade 2 - fluid visible in both SS and RLD positions (estimated GRV >300 mL, high aspiration risk).
Measured: 30 minutes after drug administration
Fasting glucose
Post-intervention fasting serum glucose was measured.
Measured: 30 minutes after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Mar 2025
- Primary completion1 Sep 2025
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Residual VolumeStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Fawzy Elsharkawy, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07519447
- Sponsor's protocol ID
- KFSIRB200-316
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Assessment of Preoperative Gastric Residual Volume and Aspiration Risk Following Intravenous Metoclopramide in Fasted Diabetic Patients Undergoing Elective Surgery Under General Anesthesia: A Prospective Non-Randomized Controlled Comparative Study
- ClinicalTrials.gov ID
- NCT07519447
- Acronym / sponsor ID
- KFSIRB200-316
- Conditions
- Gastric Residual Volume, Aspiration Risk, Metoclopramide, Fasted Diabetic Patients, Elective Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 9 Apr 2026 (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.
This study aimed to evaluate the effect of metoclopramide on preoperative gastric emptying in diabetic patients.
Detailed description
Perioperative aspiration of gastric contents is a rare but serious complication of anesthesia. Aspiration pneumonia is associated with significant morbidity, including prolonged mechanical ventilation, and carries a risk of mortality as great as 5%.
Point-of-care (POC) gastric ultrasound has gained popularity in recent times. It has been adapted in the field of anesthesiology gradually to make the clinical decision before anesthetizing patients where the fasting status is uncertain and in emergency patients where surgery is mandated.
Metoclopramide, a medication used for diabetic gastroparesis, is a cholinergic agent that acts by increasing the release of acetylcholine at the neuromuscular junction within the gastric wall. Further, metoclopramide has antidopaminergic properties that inhibit dopamine-induced gastric smooth muscle relaxation, and it also penetrates the blood-brain barrier and binds to medullary chemoreceptors.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Drug: MetoclopramideDiabetic patients received a single IV dose of metoclopramide 10 mg (2 mL) administered 30-60 minutes prior to POC gastric ultrasound assessment, to allow for peak prokinetic effect. |
| Group II | – | –Diabetic patients who did not receive metoclopramide or any other prokinetic agent preoperatively. |
| Group III | – | –Non-diabetic patients who did not receive metoclopramide, serving as a healthy reference group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study was carried out on 60 patients undergoing elective surgery admitted to Kafr- Elsheikh University Hospitals over a period of 6 months starting from approval of the Medical Sciences Ethics Committee of Kafr- Elsheikh Faculty of Medicine.
Key inclusion criteria (4 listed)
- Age from 18 to 65 years old.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status I-II.
- Underwent elective surgery.
Key exclusion criteria (8 listed)
- Patients taking drugs that affect gastric motility.
- Patients with renal failure.
- Hypothyroidism.
- Obesity [body mass index (BMI) > 30kg/m2].
- Connective tissue disorders.
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 |
|---|---|---|
| MetoclopramideDiabetic patients received a single IV dose of metoclopramide 10 mg (2 mL) administered 30-60 minutes prior to POC gastric ultrasound assessment, to allow for peak prokinetic effect. | Drug | Group I |
Primary outcome
Antral cross-sectional area
Time frame: 30 minutes after drug administration
Antral cross-sectional area (CSA) was measured by Point-of-Care (POC) ultrasound (cm²). Antral CSA was calculated using the standard ellipse formula: Antral CSA (cm²) = π/4 × antero-posterior (AP) (cm) × cranio-caudal (CC) (cm)
3 secondary outcomes
Gastric volume
Time frame: 30 minutes after drug administration
Antral gastric grade
Time frame: 30 minutes after drug administration
Fasting glucose
Time frame: 30 minutes after drug administration
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 9 Apr 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Gastric Residual Volume and Aspiration Risk, run by Kafrelsheikh 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 4 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: finished, as of the sponsor's last update on 9 Apr 2026. 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?
Antral cross-sectional area (time frame: 30 minutes after drug administration). 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 9 Apr 2026.