Oral Carbohydrate in DM Patients Undergoing Total Knee Arthroplasty

Yonsei University

Status: Completed

Conditions: Total Knee Arthroplasty

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02432781

4-2015-0151

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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82 participants in 2 patient groups

Carbohydrate group

Experimental group

Description:

Carbohydrate-rich drink 400 mL 3 h before surgery

Treatment:

Dietary Supplement: Carbohydrate-rich drink

Control group

Active Comparator group

Description:

10% dextrose solution mixed with insulin 16 unit 100 mL/h

Treatment:

Dietary Supplement: 10% dextrose solution mixed with insulin 16 unit 100 mL/h