Preoperative Gastric Volume and High-Risk Gastric Content in Patients With Type 2 Diabetes Mellitus

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBakirkoy Dr. Sadi Konuk Research and Training Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Preoperative Gastric Ultrasonography

    Diagnostic test

    The 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 test

    Capillary 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

120 Participants
are divided into 1 treatment group
Group A: Preoperative Patients With Type 2 Diabetes Mellitus2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
On the day of surgery, during the preoperative assessment immediately before anesthesia induction

Secondary outcomes

1

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 .

Time frame
On the day of surgery, during the preoperative assessment before anesthesia induction
2

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.

Time frame
On the day of surgery, during the preoperative assessment before anesthesia induction
3

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.

Time frame
On the day of surgery, during the preoperative assessment before anesthesia induction
4

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.

Time frame
On the day of surgery, during the preoperative assessment before anesthesia induction

Other outcomes

Sponsors and contacts

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