Safety of Preoperative Carbohydrate Loading in Diabetic Patients

Completed

• Conditions: Diabetes Mellitus Type 2; Carbohydrate Intolerance
• Interventions: Dietary Supplement: noNPO

• Registration Number: NCT04456166
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-22
• Study First Submitted: 2020-06-25
• Study First Submitted QC: 2020-06-29
• Study First Posted: 2020-07-02
• Primary Completion: 2021-05-04
• Study Completion: 2021-05-04
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-14
• Last Update Posted: 2021-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient who received carbohydrate loading	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

Primary Outcome Measures

Name	Time	Method
Incidence of gastric ultrasonography score as low risk (grade 0 or 1)	30 minutes after intubation	Ultrasound assessment of gastric volume by gastroscopic examination.

Secondary Outcome Measures

Name	Time	Method
The incidence of nausea and vomiting	up to 30 minutes after extubation
The incidence of insulin bolus injection	up to 30 minutes after extubation
Satisfaction scale of patients	up to 30 minutes after extubation
Gastric volume	30 minutes after intubation
Blood sugar test	30 minutes after intubation and 30 minutes after extubation

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Jongnogu, Korea, Republic of