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Completed

NCT Number: NCT02432781

Oral Carbohydrate in DM Patients Undergoing Total Knee Arthroplasty

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.

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Key information

Conditions

Total Knee Arthroplasty

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carbohydrate-rich drink

Dietary Supplement

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

Dietary Supplement

Primary outcomes

  1. Incidence of postoperative nausea and vomiting

    Time frame: 24 hours

Secondary outcomes

  1. Score of quality of recovery

    Time frame: 24 hours

    Quality of recovery is determined by a 40-item quality-of-recovery questionnaire

  2. Degree of inflammation

    Time frame: 24 hours

    Degree of inflammation is determined by white blood cell count, neutrophil count, and C-reactive protein

Sponsors and collaborators

Lead sponsor

Severance Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 4, 2015
Registry last updated
Sep 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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