Oral Carbohydrate in DM Patients Undergoing Total Knee Arthroplasty

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02432781
• Other study ID #: 4-2015-0151
• Status: Completed
• Phase: N/A
• Start date: June 25, 2015
• Est. completion date: December 14, 2017

Study information

• Verified date: September 2018
• Source: Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 14, 2017
• Est. primary completion date: December 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Nausea and Vomiting
• Total Knee Arthroplasty

Intervention

Dietary Supplement:
• Carbohydrate-rich drink

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

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative nausea and vomiting		24 hours
Secondary	Score of quality of recovery	Quality of recovery is determined by a 40-item quality-of-recovery questionnaire	24 hours
Secondary	Degree of inflammation	Degree of inflammation is determined by white blood cell count, neutrophil count, and C-reactive protein	24 hours