Safety of Preoperative Carbohydrate Loading in Diabetic Patients

NCT04456166 | Completed DMC

• 1 other identifier: 20030471108
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Carbohydrate Intolerance; Diabetes Mellitus Type 2

Keywords

Carbohydrate Intolerance; Diabetes Mellitus; Diabetes Mellitus, Type 2; Carbohydrate loading

Outcome Measures

Primary Outcomes (1)

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

  Ultrasound assessment of gastric volume by gastroscopic examination.

  30 minutes after intubation

Secondary Outcomes (6)

• Gastric volume

  30 minutes after intubation

• Blood sugar test

  30 minutes after intubation and 30 minutes after extubation

• The incidence of insulin bolus injection

  during operation

• The incidence of insulin bolus injection

  up to 30 minutes after extubation

• Satisfaction scale of patients

  up to 30 minutes after extubation

Study Arms (1)

Patient who received carbohydrate loading

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

Dietary Supplement: noNPO

Interventions

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.

Patient who received carbohydrate loading

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients over 18 years of age who are scheduled to undergo general anesthesia are subject to preoperative carbohydrodritate loading and diagnosed with type 2 diabetes taking oral hypoglycemic agents

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Jongnogu, 03080, South Korea

Location

Related Publications (1)

• Lee S, Sohn JY, Lee HJ, Yoon S, Bahk JH, Kim BR. Effect of pre-operative carbohydrate loading on aspiration risk evaluated with ultrasonography in type 2 diabetes patients: a prospective observational pilot study. Sci Rep. 2022 Oct 20;12(1):17521. doi: 10.1038/s41598-022-21696-1.

  PMID: 36266449 DERIVED

MeSH Terms

Conditions

Glucose-Galactose Malabsorption; Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Susie Yoon, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: July 2, 2020
• Study Start: June 22, 2020
• Primary Completion: May 4, 2021
• Study Completion: May 4, 2021
• Last Updated: October 15, 2021

Record last verified: 2021-10

Locations

KR (1)