Baseline Gastric Volume in Diabetic vs Non-Diabetic Patients
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorKocaeli University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages 18-75
ASA I-III
BMI ≤ 40 kg/m2
Disqualifiers
Patients with a history of gastrointestinal surgery,
Pregnant women,
Patients with documented abnormalities in the upper gastrointestinal tract, such as achalasia
Trial population
The study population consists of diabetic and non-diabetic adult patients aged 18-75 years, ASA physical status I-III, with BMI ≤40 kg/m2, scheduled for elective surgery.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Gastric Ultrasound
Procedure/SurgeryPreoperative 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.
Treatment groups
220 Participants
are divided into 2 treatment groupsGroup A: Diabetic patients1 intervention
Group B: Non-diabetic patients1 intervention
Trial outcomes
Primary outcomes
1
Preoperative residual gastric volume
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
Time frame
Preoperative periodSecondary outcomes
1
Association between diabetes severity and gastric volume
Evaluation of the relationship between diabetes severity and preoperative residual gastric volume.
Time frame
Preoperative assessment2
Baseline gastric volume comparison
Comparison of baseline gastric volume between diabetic and non-diabetic patients undergoing elective surgery.
Time frame
Preoperative assessmentSponsors and contacts
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Source ClinicalTrials.gov
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