Baseline Gastric Volume in Diabetic vs Non-Diabetic Patients
March 16, 2026 updated by: Sevim Cesur, Kocaeli University
Baseline Gastric Volume Measurement in Diabetic and Non-Diabetic Patients: A Non-Inferiority Study
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Estimated)
220
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sevim CESUR, MD
- Phone Number: +902623038248
- Email: svmcsr@gmail.com
Study Locations
-
-
-
Kocaeli, Turkey (Türkiye)
- Kocaeli University
-
Contact:
- Sevim CESUR, MD
- Phone Number: +902623038248
-
Kocaeli, Turkey (Türkiye)
- Sevim Cesur
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study 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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Diabetic patients
Patients with diabetes mellitus scheduled for elective surgery undergoing preoperative gastric ultrasound assessment to measure baseline gastric volume.
|
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.
Other Names:
|
|
Non-diabetic patients
Patients without diabetes mellitus scheduled for elective surgery undergoing preoperative gastric ultrasound assessment to measure baseline gastric volume.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preoperative residual gastric volume
Time Frame: Preoperative period
|
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
|
Preoperative period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Association between diabetes severity and gastric volume
Time Frame: Preoperative assessment
|
Evaluation of the relationship between diabetes severity and preoperative residual gastric volume.
|
Preoperative assessment
|
|
Baseline gastric volume comparison
Time Frame: Preoperative assessment
|
Comparison of baseline gastric volume between diabetic and non-diabetic patients undergoing elective surgery.
|
Preoperative assessment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Sevim CESUR, MD, Kocaeli University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 20, 2026
Primary Completion (Estimated)
August 15, 2026
Study Completion (Estimated)
November 15, 2026
Study Registration Dates
First Submitted
March 16, 2026
First Submitted That Met QC Criteria
March 16, 2026
First Posted (Actual)
March 19, 2026
Study Record Updates
Last Update Posted (Actual)
March 19, 2026
Last Update Submitted That Met QC Criteria
March 16, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GOKAEK-2025/14/33
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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