Oral Carbohydrate in DM Patients Undergoing Total Knee Arthroplasty

NCT ID: NCT02432781

Last Updated: 2018-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-25

Study Completion Date

2017-12-14

Brief Summary

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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

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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.

Conditions

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Total Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Carbohydrate group

Carbohydrate-rich drink 400 mL 3 h before surgery

Group Type EXPERIMENTAL

Carbohydrate-rich drink

Intervention Type DIETARY_SUPPLEMENT

Control group

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Carbohydrate-rich drink

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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So Yeon Kim

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Shin S, Choi YS, Shin H, Yang IH, Park KK, Kwon HM, Kang B, Kim SY. Preoperative Carbohydrate Drinks Do Not Decrease Postoperative Nausea and Vomiting in Type 2 Diabetic Patients Undergoing Total Knee Arthroplasty-A Randomized Controlled Trial. J Am Acad Orthop Surg. 2021 Jan 1;29(1):35-43. doi: 10.5435/JAAOS-D-20-00089.

Reference Type DERIVED
PMID: 32433428 (View on PubMed)

Other Identifiers

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4-2015-0151

Identifier Type: -

Identifier Source: org_study_id

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