Baseline Gastric Volume in Diabetic vs Non-Diabetic Patients

March 16, 2026 updated by: Sevim Cesur, Kocaeli University

Baseline Gastric Volume Measurement in Diabetic and Non-Diabetic Patients: A Non-Inferiority Study

During the preoperative preparation process, the fasting period for anesthesia is planned according to guidelines. According to standard guidelines, a fasting period of at least 2 hours is recommended for clear liquids, at least 6 hours for light meals, and at least 8 hours for a full meal. However, it has been reported that these guidelines are valid for healthy patients. It is thought that the planned fasting periods may vary in diabetic patients due to delayed gastric emptying. This study aims to calculate gastric volume under ultrasonography guidance and compare it with fasting time.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Aspiration of gastric contents is the most important risk factor for pulmonary aspiration. Pulmonary aspiration is a serious perioperative complication and can lead to lung damage. The main factor in the development of this complication is the presence of a "full stomach" during induction. This can result from non-compliance with fasting protocols or delayed gastric emptying. Although the incidence of gastric content aspiration is low in patients scheduled for elective surgery, the risk factor is considered increased in diabetic patients due to delayed gastric emptying caused by autonomic dysfunction. Prior to surgery, a bedside ultrasound will be performed on the morning of the operation by an experienced anesthesiologist who is unaware of the patient's diabetes mellitus status, using a standard gastric screening protocol. Evaluation of the gastric antrum will be performed by two experienced anesthesiologists using a portable ultrasound device with a convex low-frequency (2-5 MHz) probe, first in the supine position and then in the right lateral decubitus position.

Study Type

Observational

Enrollment (Estimated)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
      • Kocaeli, Turkey (Türkiye)
        • Kocaeli University
        • Contact:
          • Sevim CESUR, MD
          • Phone Number: +902623038248
      • Kocaeli, Turkey (Türkiye)
        • Sevim Cesur

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of diabetic and non-diabetic adult patients aged 18-75 years, ASA physical status I-III, with BMI ≤40 kg/m2, scheduled for elective surgery.

Description

Inclusion Criteria:

  • Ages 18-75
  • ASA I-III
  • BMI ≤ 40 kg/m2

Exclusion Criteria:

  • Patients with a history of gastrointestinal surgery,
  • Pregnant women,
  • Patients with documented abnormalities in the upper gastrointestinal tract, such as achalasia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diabetic patients
Patients with diabetes mellitus scheduled for elective surgery undergoing preoperative gastric ultrasound assessment to measure baseline gastric volume.
Procedure: Gastric Ultrasound
Preoperative gastric ultrasonography will be performed to assess gastric antral cross-sectional area and estimate residual gastric volume in patients scheduled for elective surgery. The examination will be performed in the supine and right lateral decubitus positions using a low-frequency convex probe by experienced anesthesiologists.
Other Names:
  • Preoperative Gastric Ultrasound
Non-diabetic patients
Patients without diabetes mellitus scheduled for elective surgery undergoing preoperative gastric ultrasound assessment to measure baseline gastric volume.
Procedure: Gastric Ultrasound
Preoperative gastric ultrasonography will be performed to assess gastric antral cross-sectional area and estimate residual gastric volume in patients scheduled for elective surgery. The examination will be performed in the supine and right lateral decubitus positions using a low-frequency convex probe by experienced anesthesiologists.
Other Names:
  • Preoperative Gastric Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative residual gastric volume
Time Frame: Preoperative period
Assessment of whether standard preoperative fasting guidelines provide an empty stomach in diabetic patients by comparing estimated residual gastric volume measured with gastric ultrasonography between diabetic and non-diabetic patients scheduled for elective surgery
Preoperative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between diabetes severity and gastric volume
Time Frame: Preoperative assessment
Evaluation of the relationship between diabetes severity and preoperative residual gastric volume.
Preoperative assessment
Baseline gastric volume comparison
Time Frame: Preoperative assessment
Comparison of baseline gastric volume between diabetic and non-diabetic patients undergoing elective surgery.
Preoperative assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Investigators

  • Study Director: Sevim CESUR, MD, Kocaeli University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 20, 2026

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

November 15, 2026

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOKAEK-2025/14/33

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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