NCT07483593

Baseline Gastric Volume in Diabetic vs Non-Diabetic Patients

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 220 (estimated)
• Sponsor: Kocaeli University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Gastric Volume
• Preoperative Fasting
• Diabetes Mellitus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-04-20
• Primary completion: 2026-08-15
• Completion: 2026-11-15
• First posted: 2026-03-19
• Last updated: 2026-03-19

Locations

2 sites across 1 country: Turkey (Türkiye)