Safety of Preoperative Carbohydrate Loading in Diabetic Patients (NoNPO)

Safety of Preoperative Carbohydrate Loading in Diabetic Patients Undergoing General Anesthesia

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus Type 2; Carbohydrate Intolerance
• Intervention / Treatment: Dietary supplement: noNPO

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jongnogu
    • Seoul, Jongnogu, Korea, Republic of, 03080
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
The incidence of nausea and vomiting	up to 30 minutes after extubation

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Susie Yoon, MD, Seoul National University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2020
• Primary Completion (Actual): May 4, 2021
• Study Completion (Actual): May 4, 2021

Study Registration Dates

• First Submitted: June 25, 2020
• First Submitted That Met QC Criteria: June 29, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 14, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Diabetes Mellitus, Type 2; Carbohydrate loading; Carbohydrate Intolerance
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 20030471108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No