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Completed

NCT Number: NCT07519447

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

This study aimed to evaluate the effect of metoclopramide on preoperative gastric emptying in diabetic patients.

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Key information

Conditions

Gastric Residual Volume Aspiration Risk Elective Surgery Fasted Diabetic Patients Metoclopramide

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Metoclopramide

Drug

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Gastric volume

    Time frame: 30 minutes after drug administration

    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

  2. Antral gastric grade

    Time frame: 30 minutes after drug administration

    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).

  3. Fasting glucose

    Time frame: 30 minutes after drug administration

    Post-intervention fasting serum glucose was measured.

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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