Total Knee ArthroplastyNCT02432781
Oral Carbohydrate in DM Patients Undergoing Total Knee Arthroplasty
A study testing Carbohydrate-rich drink and 10% dextrose solution mixed with insulin 16 unit 100 mL/h in people with Total Knee Arthroplasty, run by Severance Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Carbohydrate-rich drink and 10% dextrose solution mixed with insulin 16 unit 100 mL/h
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Jun 2015to 14 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 DM patients undergoing elective total knee arthroplasty
Who cannot join
- Contraindication to regional anesthesia
- Patients whose operation is scheduled to start after 9:00 am
- Dementia or cognitive dysfunction
- HbA1c > 8%
- Gastroesophageal reflux disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine
Seoul
About this study
Official title: Effect of Preoperative Oral Carbohydrates on Postoperative Nausea and Vomiting and Quality of Recovery 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.
Read the detailed 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.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Carbohydrate-rich drink, 10% dextrose solution mixed with insulin 16 unit 100 mL/h
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate-rich drinkDietary supplement
10% dextrose solution mixed with insulin 16 unit 100 mL/hDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate group | Experimental | Carbohydrate-rich drink 400 mL 3 h before surgery Receives: Dietary Supplement: Carbohydrate-rich drink |
| Control group | Active comparator | 10% dextrose solution mixed with insulin 16 unit 100 mL/h Receives: Dietary Supplement: 10% dextrose solution mixed with insulin 16 unit 100 mL/h |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative nausea and vomiting
Measured: 24 hours
Secondary outcomes (2)
Score of quality of recovery
Quality of recovery is determined by a 40-item quality-of-recovery questionnaire
Measured: 24 hours
Degree of inflammation
Degree of inflammation is determined by white blood cell count, neutrophil count, and C-reactive protein
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study start25 Jun 2015
- Primary completion14 Dec 2017
- Study completion14 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, So Yeon Kim, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02432781
- Sponsor's protocol ID
- 4-2015-0151
- Status last verified
- Sep 2018
- First submitted
- 23 Apr 2015
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32433428
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Oral Carbohydrates on Postoperative Nausea and Vomiting and Quality of Recovery in DM Patients Undergoing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02432781
- Acronym / sponsor ID
- 4-2015-0151
- Conditions
- Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Study start
- 25 Jun 2015 (actual)
- Primary completion
- 14 Dec 2017 (actual)
- Study completion
- 14 Dec 2017 (actual)
- First posted
- 4 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate group | Experimental | Dietary Supplement: Carbohydrate-rich drinkCarbohydrate-rich drink 400 mL 3 h before surgery |
| Control group | Active comparator | Dietary Supplement: 10% dextrose solution mixed with insulin 16 unit 100 mL/h10% dextrose solution mixed with insulin 16 unit 100 mL/h |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Type 2 DM patients undergoing elective total knee arthroplasty
Key exclusion criteria (5 listed)
- Contraindication to regional anesthesia
- Patients whose operation is scheduled to start after 9:00 am
- Dementia or cognitive dysfunction
- HbA1c > 8%
- Gastroesophageal reflux disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbohydrate-rich drink | Dietary supplement | Carbohydrate group |
| 10% dextrose solution mixed with insulin 16 unit 100 mL/h | Dietary supplement | Control group |
Primary outcome
Incidence of postoperative nausea and vomiting
Time frame: 24 hours
2 secondary outcomes
Score of quality of recovery
Time frame: 24 hours
Degree of inflammation
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Derived from this study: PubMed 32433428Shin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate-rich drink and 10% dextrose solution mixed with insulin 16 unit 100 mL/h in people with Total Knee Arthroplasty, run by Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative nausea and vomiting (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02432781, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018.