Oral Carbohydrate in DM Patients Undergoing Total Knee Arthroplasty

Study Overview
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Brief Summary
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The primary purpose of this study is to investigate the effects of carbohydrate-rich drink on postoperative nausea and vomiting in diabetic patients undergoing total knee arthroplasty. The secondary purpose is to investigate the effects of carbohydrate-rich drink on quality of recovery and inflammation in diabetic patients after total knee arthroplasty.

Detailed Description
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Carbohydrate-rich drink has been proved to neither delay gastric emptying nor affect gastric acidity and is therefore considered safe to use in elective surgical patients without risk factors for pulmonary aspiration. It reduced postoperative nausea and vomiting and improved sense of well-being after surgery. Moreover, carbohydrate-rich drink was not found to be affected by delayed gastric emptying in patients with uncomplicated type 2 diabetes. Therefore, carbohydrate drink may be safely administered 3 h before anesthesia without risk of hyperglycemia or aspiration.

Official Title
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Effect of Preoperative Oral Carbohydrates on Postoperative Nausea and Vomiting and Quality of Recovery in DM Patients Undergoing Total Knee Arthroplasty

Conditions
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Total Knee Arthroplasty

Intervention / Treatment
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* Dietary Supplement: Carbohydrate-rich drink
* Dietary Supplement: 10% dextrose solution mixed with insulin 16 unit 100 mL/h


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 DM patients undergoing elective total knee arthroplasty Exclusion Criteria: Contraindication to regional anesthesia Patients whose operation is scheduled to start after 9:00 am Dementia or cognitive dysfunction HbA1c > 8% Gastroesophageal reflux disease

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carbohydrate group<br>Carbohydrate-rich drink 400 mL 3 h before surgery | Dietary Supplement: Carbohydrate-rich drink<br> <br> |
| Active Comparator: Control group<br>10% dextrose solution mixed with insulin 16 unit 100 mL/h | Dietary Supplement: 10% dextrose solution mixed with insulin 16 unit 100 mL/h<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative nausea and vomiting |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score of quality of recovery | Quality of recovery is determined by a 40-item quality-of-recovery questionnaire | 24 hours | 
| Degree of inflammation | Degree of inflammation is determined by white blood cell count, neutrophil count, and C-reactive protein | 24 hours |