NCT07375680

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
4mo left

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress41%
Feb 2026Sep 2026

First Submitted

Initial submission to the registry

January 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

February 15, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2026

Expected
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

January 22, 2026

Last Update Submit

April 6, 2026

Conditions

Keywords

Hemoglobin A1cGastric UltrasonographyGeneral AnesthesiaPreoperative Assessment

Outcome Measures

Primary Outcomes (1)

  • Gastric emptying assessed by gastric ultrasound

    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.

    The preoperative period,immediately before induction of anesthesia

Study Arms (1)

Study Population

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients aged 18 to 70 years scheduled for elective surgery under general anesthesia at a tertiary care hospital.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Science University Training and Research Hospital

Kütahya, Kütahya, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

GastroparesisDiabetes Mellitus

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • merve yaman, MD, Assistant Professor

    Kutahya Health Science University

    PRINCIPAL INVESTIGATOR
  • emine gök, MD

    Kutahya Health Science University

    STUDY DIRECTOR

Central Study Contacts

merve yaman, MD, Assistant Professor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,Assistant Professor of Anesthesiology

Study Record Dates

First Submitted

January 22, 2026

First Posted

January 29, 2026

Study Start

February 15, 2026

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations