Oral Carbohydrate in DM Patients Undergoing Total Knee Arthroplasty

Not Applicable

Completed

• Conditions: Total Knee Arthroplasty
• Interventions: Dietary Supplement: Carbohydrate-rich drink; Dietary Supplement: 10% dextrose solution mixed with insulin 16 unit 100 mL/h

• Registration Number: NCT02432781
• Lead Sponsor: Severance Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-04-23
• Study First Submitted QC: 2015-04-28
• Study First Posted: 2015-05-04
• Study Start: 2015-06-25
• Primary Completion: 2017-12-14
• Study Completion: 2017-12-14
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• Type 2 DM patients undergoing elective total knee arthroplasty

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carbohydrate group	Carbohydrate-rich drink	Carbohydrate-rich drink 400 mL 3 h before surgery
Control group	10% dextrose solution mixed with insulin 16 unit 100 mL/h	10% dextrose solution mixed with insulin 16 unit 100 mL/h

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative nausea and vomiting	24 hours

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of