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

NCT07519447 | Completed

• 1 other identifier: KFSIRB200-316
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastric Residual Volume; Aspiration Risk; Metoclopramide; Fasted Diabetic Patients; Elective Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Gastric volume

  30 minutes after drug administration

• Antral gastric grade

  30 minutes after drug administration

• Fasting glucose

  30 minutes after drug administration

Study Arms (3)

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

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.

Interventions

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.

Group I

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

Location

MeSH Terms

Interventions

Metoclopramide

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Surgical Intensive Care and Pain Management, Faculty of Medicine, Kafr Elsheikh University, Kafr Elsheikh, Egypt.

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 9, 2026
• Study Start: March 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)