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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07483593
Enrollment
220
Registered
2026-03-19
Start date
2026-04-20
Completion date
2026-11-15
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Gastric Volume, Preoperative Fasting

Keywords

Gastric Ultrasound, Gastric Volume, Diabetes Mellitus

Brief 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.

Interventions

PROCEDUREGastric 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.

Sponsors

Kocaeli University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Preoperative residual gastric volumePreoperative periodAssessment 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

MeasureTime frameDescription
Association between diabetes severity and gastric volumePreoperative assessmentEvaluation of the relationship between diabetes severity and preoperative residual gastric volume.
Baseline gastric volume comparisonPreoperative assessmentComparison of baseline gastric volume between diabetic and non-diabetic patients undergoing elective surgery.

Countries

Turkey (Türkiye)

Contacts

CONTACTSevim CESUR, MD
svmcsr@gmail.com+902623038248
STUDY_DIRECTORSevim CESUR, MD

Kocaeli University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026