NoNPO: Safety of Preoperative Carbohydrate Loading in Diabetic Patients

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04456166

Collaborator

(none)

Enrollment

Location

10.4

Actual Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Carbohydrate Intolerance Diabetes Mellitus Type 2	Dietary Supplement: noNPO

Study Design

Study Type:

Observational

Actual Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Safety of Preoperative Carbohydrate Loading in Diabetic Patients Undergoing General Anesthesia

Actual Study Start Date :

Jun 22, 2020

Actual Primary Completion Date :

May 4, 2021

Actual Study Completion Date :

May 4, 2021

Arms and Interventions

Arm	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.

Arm

Intervention/Treatment

Patient who received carbohydrate loading

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.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul	Jongnogu	Korea, Republic of	03080

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator: Susie Yoon, MD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Susie Yoon, Clinical Assistant Professor, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT04456166

Other Study ID Numbers:

20030471108

First Posted:

Jul 2, 2020

Last Update Posted:

Oct 15, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Susie Yoon, Clinical Assistant Professor, Seoul National University Hospital

Carbohydrate Intolerance

Diabetes Mellitus

Diabetes Mellitus, Type 2

Carbohydrate loading

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Oct 15, 2021