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NCT04456166 Clinical Trial

Safety of Preoperative Carbohydrate Loading in Diabetic Patients

Diabetes Mellitus Type 2 Clinical Trial

— NoNPO  

Official title:
Safety of Preoperative Carbohydrate Loading in Diabetic Patients Undergoing General Anesthesia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04456166
Other study ID # 20030471108
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 22, 2020
Est. completion date May 4, 2021

Study information
Verified date October 2021
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date May 4, 2021
Est. primary completion date May 4, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul Jongnogu

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Gastric volume 30 minutes after intubation
Secondary Blood sugar test 30 minutes after intubation and 30 minutes after extubation
Secondary The incidence of insulin bolus injection during operation
Secondary The incidence of insulin bolus injection up to 30 minutes after extubation
Secondary Satisfaction scale of patients up to 30 minutes after extubation
Secondary The incidence of nausea and vomiting up to 30 minutes after extubation
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