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Completed

NCT Number: NCT04456166

Safety of Preoperative Carbohydrate Loading in Diabetic Patients

The purpose of this study is to investigate the safety of preoperative carbohydrate loading in diabetic patients undergoing general anesthesia

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Key information

Conditions

Carbohydrate Intolerance Diabetes Mellitus Diabetes Mellitus Type 2 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Glucose-Galactose Malabsorption Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, Jongnogu, 03080, South Korea

Who can participate

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

Inclusion criteria

  • Elective surgery
  • Type 2 diabetes mellitus on oral hypoglycemic agents
  • American Society of Anesthesiologists physical status 2 or 3
  • Ages 18 or more
  • Approve to participate

Exclusion criteria

  • Ambulatory surgery
  • BMI >35
  • History of gastric or esophagus surgery
  • History of GERD, dyspepesia or
  • Anticipated difficult intubation (previous III or more Cormack and Lehane's grade, Mallamgrade, Mallampati scpati scoreore III or moreIII or more, propro/retro/retrognathism, gnathism, thyromental distance<6.5cm, thyromental distance<6.5cm, limited mouth openinglimited mouth opening)

Treatment and study plan

noNPO

Dietary Supplement

Patients with diabetes mellitus type 2 who are planned to receive a carbohydrate beverage (400 ml (12.8% carbohydrates, 50 kcal/100 ml; Nucare NONPO Ⓡ , Daesang Wellife, Korea) before the operation and up to 2 hours before the induction of anesthesia outside this clinical study setting will be asked to be enrolled into the study.

Before induction of general anesthesia, all patients were evaluated the gastric volume under ultrasonography.

Primary outcomes

  1. Incidence of gastric ultrasonography score as low risk (grade 0 or 1)

    Time frame: 30 minutes after intubation

    Ultrasound assessment of gastric volume by gastroscopic examination.

Secondary outcomes

  1. Gastric volume

    Time frame: 30 minutes after intubation

  2. Blood sugar test

    Time frame: 30 minutes after intubation and 30 minutes after extubation

  3. The incidence of insulin bolus injection

    Time frame: during operation

  4. The incidence of insulin bolus injection

    Time frame: up to 30 minutes after extubation

  5. Satisfaction scale of patients

    Time frame: up to 30 minutes after extubation

  6. The incidence of nausea and vomiting

    Time frame: up to 30 minutes after extubation

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Safety of Preoperative Carbohydrate Loading in Diabetic Patients Undergoing General Anesthesia

Acronym: NoNPO

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 2, 2020
Registry last updated
Oct 15, 2021

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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