Gastric Ultrasound in Diabetic Patients

NCT ID: NCT06195488

Last Updated: 2025-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-15

Study Completion Date

2025-01-01

Brief Summary

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The American Society of Anesthesiologists (ASA) does not specify a fasting period for patients with certain comorbidities, such as diabetes, for elective surgery, and does not make a separate recommendation for surgery.

The European Society of Anesthesiology (ESA) guidelines do not differentiate between diabetic patients and normal patients. Aspiration of gastric contents is a common cause of perioperative morbidity and mortality.

Aspiration can cause hypoxia, bronchospasm, pneumonia, acute respiratory distress syndrome and death.

The presence of food or fluid in the stomach before induction of anesthesia is one of the greatest risk factors for perioperative pulmonary aspiration. Sedation and general anesthesia suppress or inhibit physiologic mechanisms (tone of the lower esophageal sphincter and upper airway reflexes) that protect against aspiration.

Because restriction of fluid and food intake before general anesthesia is vital for patient safety, Anesthesiology societies have developed guidelines for preoperative fasting.

Current ASA guidelines recommend at least 2 hours fasting for clear liquids, 6 hours fasting after a light meal (toast and clear liquids) and 8 hours fasting after a high calorie or fat meal. The information obtained from gastric ultrasound allows anesthesiologists to determine the optimal timing of procedures, type of anesthesia and airway management technique.

Detailed Description

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Conditions

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Gastric Emptying Diabetes Ultrasound

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group D

Group Diabetic

Gastric ultrasound

Intervention Type PROCEDURE

performing gastric ultrasound to determine gastric contents

Group Control

Non-diabetic patients

Gastric ultrasound

Intervention Type PROCEDURE

performing gastric ultrasound to determine gastric contents

Interventions

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Gastric ultrasound

performing gastric ultrasound to determine gastric contents

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Written informed consent obtained 40-65 BMI\<40 ASA I-III Fasting for at least 8 hours Elective surgery

Exclusion Criteria

* Pregnancy Upper gastrointestinal malignancy Large Hiatal Hernia Kidney failure Liver failure Opioid use Use of drugs affecting motility Previous upper abdominal surgery BMI ≥40 kg/m2 Emergency surgery Diabetic ketoacidosis Sepsis
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zonguldak Bulent Ecevit University

OTHER

Sponsor Role lead

Responsible Party

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Bengü Gülhan Köksal

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zonguldak Bülent Ecevit University Medicine Faculty

Zonguldak, Kozlu, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2022/17-1

Identifier Type: -

Identifier Source: org_study_id

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