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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02432781
Other study ID # 4-2015-0151
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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