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NCT Number: NCT07483593

Baseline Gastric Volume in Diabetic vs Non-Diabetic Patients

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kocaeli University, Kocaeli, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Gastric Ultrasound

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Association between diabetes severity and gastric volume

    Time frame: Preoperative assessment

    Evaluation of the relationship between diabetes severity and preoperative residual gastric volume.

  2. Baseline gastric volume comparison

    Time frame: Preoperative assessment

    Comparison of baseline gastric volume between diabetic and non-diabetic patients undergoing elective surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Sevim CESUR, MD

CONTACT

[email protected]

+902623038248

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2026
Registry last updated
Mar 19, 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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