Residual Gastric Volume Measured by Ultrasound in Diabetic Surgical Population Versus Non-diabetic Surgical Population.

NCT ID: NCT05435157

Last Updated: 2025-05-02

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

296 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-09

Study Completion Date

2024-12-31

Brief Summary

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Comparison of residual gastric volume measure by ultrasounds between diabetic and non-diabetic patients scheduled for elective surgery

Detailed Description

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The presence of gastric content increases the risk of aspiration during general anesthesia. Delayed gastric emptying has been described in diabetic patients; for that reason, diabetic patients could have a high risk of aspiration despite adequate fasting. This study aimed to compare ultrasound-guided measurement of residual gastric volume between diabetic and non-diabetic patients scheduled for elective surgery.

Conditions

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Diabetes Mellitus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Diabetic patients

Diabetic patients undergoing scheduled surgery

No interventions assigned to this group

Non-diabetic patients

Non-diabetic patients undergoing sheduled surgery

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* BMI\<40 kg.m-2;
* Age over 18 years;
* American Society of Anesthesiologists' physical status status I-III
* who were to undergo elective surgery and had the ability to understand the rationale of the study and provide informed consent

Exclusion Criteria

* Pregnancy
* Recent upper gastrointestinal bleed (\< 1 month)
* Abnormal anatomy of the upper gastrointestinal tract (such as hiatal hernias and gastric tumors)
* Previous surgical procedures on the esophagus, stomach, or upper abdomen
* Gastroesophageal reflux disease
* Previous use of prokinetics or high doses of opiates.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

OTHER

Sponsor Role lead

Responsible Party

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Jose Alfonso Sastre

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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José A. Sastre, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Anesthesiology Service. Salamanca University Hospital

Locations

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IBSAL

Salamanca, Salamanca, Spain

Site Status

Countries

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Spain

References

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Sastre JA, Lopez T, Julian R, Bustos D, Sanchis-Dux R, Molero-Diez YB, Sanchez-Tabernero A, Ruiz-Simon FA, Sanchez-Hernandez MV, Gomez-Rios MA. Assessing Full Stomach Prevalence with Ultrasound Following Preoperative Fasting in Diabetic Patients with Dysautonomia: A Comparative Observational Study. Anesth Analg. 2024 Dec 1;139(6):1300-1308. doi: 10.1213/ANE.0000000000007110. Epub 2024 Aug 8.

Reference Type BACKGROUND
PMID: 39116006 (View on PubMed)

Other Identifiers

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PI 2022 02 934

Identifier Type: -

Identifier Source: org_study_id

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