NCT02432781

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 4, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

June 25, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2017

Completed
Last Updated

September 6, 2018

Status Verified

September 1, 2018

Enrollment Period

2.5 years

First QC Date

April 23, 2015

Last Update Submit

September 4, 2018

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative nausea and vomiting

    24 hours

Secondary Outcomes (2)

  • Score of quality of recovery

    24 hours

  • Degree of inflammation

    24 hours

Study Arms (2)

Carbohydrate group

EXPERIMENTAL

Carbohydrate-rich drink 400 mL 3 h before surgery

Dietary Supplement: Carbohydrate-rich drink

Control group

ACTIVE COMPARATOR

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

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

Interventions

Carbohydrate-rich drinkDIETARY_SUPPLEMENT
Carbohydrate group
10% dextrose solution mixed with insulin 16 unit 100 mL/hDIETARY_SUPPLEMENT
Control group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 DM patients undergoing elective total knee arthroplasty

You may not qualify if:

  • Contraindication to regional anesthesia
  • Patients whose operation is scheduled to start after 9:00 am
  • Dementia or cognitive dysfunction
  • HbA1c \> 8%
  • Gastroesophageal reflux disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 32433428DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

April 23, 2015

First Posted

May 4, 2015

Study Start

June 25, 2015

Primary Completion

December 14, 2017

Study Completion

December 14, 2017

Last Updated

September 6, 2018

Record last verified: 2018-09

Locations

KR(1)