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Clinical Trials/NCT07375680
NCT07375680Not yet recruitingNot Applicable

Evaluation of the Effect of Hemoglobin A1c Levels on Gastric Emptying Assessed by Gastric Ultrasound

Kutahya Health Sciences University1 site in 1 country134 target enrollmentStarted: January 1, 2026Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
134
Locations
1
Primary Endpoint
Gastric emptying assessed by gastric ultrasound

Study Overview

Brief Summary

Delayed gastric emptying increases the risk of pulmonary aspiration during general anesthesia. Diabetes mellitus and poor long-term glycemic control have been associated with impaired gastric motility. Hemoglobin A1c (HbA1c) is a marker of long-term glycemic control; however, its relationship with gastric emptying in surgical patients is not fully understood.

This prospective observational study aims to evaluate the association between HbA1c levels and gastric emptying using preoperative bedside gastric ultrasonography. Adult patients scheduled for elective surgery under general anesthesia will undergo gastric ultrasound examination after standard fasting. Gastric antral cross-sectional area and estimated gastric volume will be assessed and compared according to HbA1c levels.

The findings of this study may help improve preoperative risk stratification for aspiration and support individualized anesthetic management in patients with impaired glycemic control.

Detailed Description

This prospective observational study is designed to evaluate the relationship between hemoglobin A1c (HbA1c) levels and gastric emptying in adult surgical patients using bedside gastric ultrasonography.

Adult patients aged 18 to 70 years, scheduled for elective surgery under general anesthesia, will be enrolled. After standard preoperative fasting according to current guidelines, all participants will undergo a preoperative gastric ultrasound examination performed by a trained anesthesiologist. The gastric antrum will be assessed in standardized positions, and the antral cross-sectional area will be measured. Estimated gastric volume will be calculated using validated ultrasound-based formulas.

HbA1c levels will be obtained from preoperative laboratory records, and patients will be analyzed according to their HbA1c values. Gastric ultrasound findings, including antral cross-sectional area and estimated gastric volume, will be compared across different HbA1c levels.

Demographic data, anthropometric measurements including body mass index and waist circumference, fasting duration, and relevant clinical characteristics will also be recorded. The primary objective is to assess the association between HbA1c levels and gastric emptying parameters. Secondary analyses will explore potential factors associated with delayed gastric emptying.

The results of this study may contribute to improved preoperative risk assessment for pulmonary aspiration and support individualized anesthetic management in patients with impaired glycemic control.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adults aged 18 to 70 years. ASA physical status I-III. Scheduled for elective surgery under general anesthesia. Ability to provide written informed consent.

Exclusion Criteria

  • Scheduled for emergency surgery. Refusal or inability to provide informed consent. Pregnancy. Age <18 years or >70 years. History of gastric surgery. Neuromuscular disease. Current use of opioid or anticholinergic medications.

Arms & Interventions

Study Population

Adult patients scheduled for elective surgery under general anesthesia who undergo preoperative bedside gastric ultrasonography as part of an observational study.

Outcomes

Primary Outcomes

Gastric emptying assessed by gastric ultrasound

Time Frame: The preoperative period,immediately before induction of anesthesia

Gastric emptying will be assessed preoperatively using bedside gastric ultrasonography by measuring gastric antrum cross-sectional area and estimating gastric volume with validated ultrasound-based methods.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Kutahya Health Sciences University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Merve Yaman

MD,Assistant Professor of Anesthesiology

Kutahya Health Sciences University

Study Sites (1)

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