Gastric Residual Volume and Aspiration Risk Following Intravenous Metoclopramide in Fasted Diabetic Patients Undergoing Elective Surgery

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.

Study Overview

• Status: Completed
• Conditions: Gastric Residual Volume; Metoclopramide; Elective Surgery; Aspiration Risk; Fasted Diabetic Patients
• Intervention / Treatment: Drug: Metoclopramide

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Egypt
  • Kafrelsheikh
    • Kafr ash Shaykh, Kafrelsheikh, Egypt, 33516
      • Kafrelsheikh University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• Age from 18 to 65 years old.
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status I-II.
• Underwent elective surgery.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Metoclopramide; 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.
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	30 minutes after drug administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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).	30 minutes after drug administration
Fasting glucose	Post-intervention fasting serum glucose was measured.	30 minutes after drug administration

Collaborators and Investigators

• Sponsor: Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Actual): September 1, 2025
• Study Completion (Actual): September 1, 2025

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Carboxylic Acids; Hydroxy Acids; Hydrocarbons, Aromatic; Amides; Phenols; Benzene Derivatives; Acids, Carbocyclic; para-Aminobenzoates; Aminobenzoates; Benzoates; Hydroxybenzoates; Phenyl Ethers; Benzamides; Chlorobenzoates; Hydroxybenzoate Ethers; Metoclopramide
• Other Study ID Numbers: KFSIRB200-316

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No