About this trial
This prospective observational study will evaluate adult patients with type 2 diabetes mellitus who are scheduled for elective surgery. Immediately before preoperative gastric ultrasonography, capillary fasting blood glucose will be measured.
Gastric contents will be assessed qualitatively in the supine and right lateral decubitus positions, and residual gastric volume will be estimated using the antral cross-sectional area measured in the right lateral decubitus position.
The primary objective is to evaluate the association between fasting capillary blood glucose and the presence of a high-risk stomach. A high-risk stomach will be defined as the presence of solid gastric contents, Perlas Grade 2 gastric contents, or an estimated gastric volume greater than 1.5 mL/kg.
Secondary objectives include determining the prevalence of a high-risk stomach and evaluating its associations with demographic characteristics, diabetes-related factors, comorbidities, fasting duration, medication use, gastroparesis-related symptoms, and routine laboratory parameters.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Diagnosis of type 2 diabetes mellitus
American Society of Anesthesiologists (ASA) physical status II or III
Scheduled for elective surgery
Disqualifiers
Pregnancy
Body mass index ≥40 kg/m²
Emergency surgery
History of gastric, esophageal, or upper gastrointestinal surgery
Trial population
Adult patients with type 2 diabetes mellitus who are scheduled for elective surgery at University of Health Sciences, Bakirkoy Dr. Sadi Konuk Training and Research Hospital and who meet the study eligibility criteria.
Trial design
Cohort
Prospective
Treatments tested in this trial
Preoperative Gastric Ultrasonography
Diagnostic testThe gastric antrum will be evaluated in the supine and right lateral decubitus positions before anesthesia induction and sedative premedication. Gastric contents will be assessed qualitatively, and antral cross-sectional area and estimated residual gastric volume will be calculated quantitatively.
Capillary Fasting Blood Glucose Measurement
Diagnostic testCapillary fasting blood glucose will be measured by fingertip sampling immediately before gastric ultrasonography. The measured glucose concentration will be evaluated as the primary exposure variable in relation to high-risk gastric findings.
Treatment groups
Trial outcomes
Primary outcomes
Presence of a High-Risk Stomach
A high-risk stomach will be defined as the presence of at least one of the following findings on preoperative gastric ultrasonography: solid gastric contents; clear fluid visible in both the supine and right lateral decubitus positions (Perlas Grade 2); or an estimated gastric volume greater than 1.5 mL/kg.
Secondary outcomes
Association Between Age and High-Risk Stomach
Age will be recorded in years from the patient's medical record. The association between age and the presence of a high-risk stomach (yes/no) will be evaluated .
Association Between Sex and High-Risk Stomach
Sex will be recorded as male or female from the patient's medical record. The association between sex and the presence of a high-risk stomach (yes/no) will be evaluated.
Association Between Body Mass Index and High-Risk Stomach
Body mass index will be calculated as body weight in kilograms divided by height in meters squared and reported in kg/m². The association between body mass index and the presence of a high-risk stomach (yes/no) will be evaluated.
Association Between Duration of Type 2 Diabetes Mellitus and High-Risk Stomach
Duration of type 2 diabetes mellitus will be recorded in years based on the patient's medical history and medical records. Its association with the presence of a high-risk stomach (yes/no) will be evaluated.
Sponsors and contacts
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