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Completed

NCT Number: NCT05435157

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

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

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IBSAL

Salamanca, 37007, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Residual Gastric Volume

    Time frame: Preoperative

    Residual gastric volume measured by ultrasounds as follows: Volume (mL) = 27.0 + 14.6 × CSARLD (cm²) - 1.28 × age (years)

Secondary outcomes

  1. Antral Cross-Sectional Area

    Time frame: Preoperative

    Antral cross-sectional area measured by ultrasounds

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Comparative Observational Study of Residual Gastric Volume Measured by Ultrasound After Preoperative Fasting in a Diabetic Surgical Population Versus a Non-diabetic Surgical Population.

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 28, 2022
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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