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Safety of Preoperative Carbohydrate Loading in Diabetic Patients

Safety of Preoperative Carbohydrate Loading in Diabetic Patients Undergoing General Anesthesia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04456166
Acronym
NoNPO
Enrollment
60
Registered
2020-07-02
Start date
2020-06-22
Completion date
2021-05-04
Last updated
2021-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carbohydrate Intolerance, Diabetes Mellitus Type 2

Keywords

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

Brief summary

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

Interventions

DIETARY_SUPPLEMENTnoNPO

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.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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)

Design outcomes

Primary

MeasureTime frameDescription
Incidence of gastric ultrasonography score as low risk (grade 0 or 1)30 minutes after intubationUltrasound assessment of gastric volume by gastroscopic examination.

Secondary

MeasureTime frame
Gastric volume30 minutes after intubation
Blood sugar test30 minutes after intubation and 30 minutes after extubation
The incidence of insulin bolus injectionduring operation
Satisfaction scale of patientsup to 30 minutes after extubation
The incidence of nausea and vomitingup to 30 minutes after extubation

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026