Effects of Preoperative Carbohydrate Rich Drinks on Immediate Postoperative Outcome in Total Knee Arthroplasty
PONV
1 other identifier
interventional
150
1 country
1
Brief Summary
The aim of this study is to investigate the effect of preoperative carbohydrate rich drinks on postoperative nausea and vomiting in total knee arthroplasty. This is a prospective, double blinded, randomized controlled trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 15, 2017
CompletedFirst Submitted
Initial submission to the registry
October 31, 2017
CompletedFirst Posted
Study publicly available on registry
December 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedFebruary 17, 2020
February 1, 2020
2 years
October 31, 2017
February 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Post operative nausea
Nausea, assess by questionnaire, 10 point scale (0 = no nausea, 10 = very nauseous, and medical record.
4 hours postoperatively
Post operative nausea
Nausea, assess by questionnaire, 10 point scale (0 = no nausea, 10 = very nauseous, and medical record.
12 hours postoperatively
Post operative nausea
Nausea, assess by questionnaire, 10 point scale (0 = no nausea, 10 = very nauseous, and medical record.
24 hours postoperatively
Post operative vomiting
Vomiting, assess by questionnaire, 10 point scale (0 = no vomiting, 10 = copious emesis, and medical record notes of emesis.
4 hours postoperatively
Post operative vomiting
Vomiting, assess by questionnaire, 10 point scale (0 = no vomiting, 10 = copious emesis, and medical record notes of emesis.
12 hours postoperatively
Post operative vomiting
Vomiting, assess by questionnaire, 10 point scale (0 = no vomiting, 10 = copious emesis, and medical record notes of emesis.
24 hours postoperatively
Secondary Outcomes (5)
Length of hospital stay
From the time of hospital admission following surgery, until the time of hospital discharge as recorded in EMR, assessed up to 1 month
Post operative opiate consumption
From the time of surgery until the time of hospital discharge, assessed up to 72 hours postoperatively
Post operative pain scores
From the time of surgery until the time of hospital discharge, assessed up to 72 hours postoperatively
Peri operative hunger and discomfort
4 hours, 12 hours, and 24 hours postoperatively
Incidence of secondary adverse events
From the time of surgery until the time of hospital discharge, assessed up to 1 month postoperatively
Study Arms (3)
Carbohydrate Rich Drink
EXPERIMENTALGroup A will receive the carbohydrate rich drink, Nutricia preOp. This is the intervention group.
Placebo Drink
PLACEBO COMPARATORGroup B will receive placebo, Nestle Splash Lemon Flavor Water (Placebo) (similarly flavored and appearing water, however with no calorie, carbohydrate or nutritional content).
No Drink
NO INTERVENTIONGroup C will not receive any drink. This group will follow normal protocol.
Interventions
A clear, non-carbonated lemon-flavored, iso-osmolar carbohydrate drink for preoperative surgical patients. Used in studies supporting the Enhanced Recovery After Surgery (ERAS) Society Consensus Guidelines.
Placebo control drink. PURIFIED WATER, NATURAL FLAVORS, CITRIC ACID, SODIUM POLYPHOSPHATE, POTASSIUM SORBATE (PRESERVE FRESHNESS), POTASSIUM BENZOATE (PRESERVE FRESHNESS), SUCRALOSE, ACESULFAME POTASSIUM, CALCIUM DISODIUM EDTA, MAGNESIUM SULFATE.
Eligibility Criteria
You may qualify if:
- Adult patients (\>18 years of age) scheduled for elective, unilateral, primary total knee arthroplasty
- Able to give valid consent
You may not qualify if:
- Impaired gastrointestinal motility
- On pro-motility medication
- Pregnancy
- HbA1c \> 7.5
- Fasting glucose \>200
- Acquired immunodeficiency
- Renal failure (creatinine \> 2 mg/dL)
- Cirrhosis
- Severe malnutrition.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Related Publications (1)
Kadado A, Shaw JH, Ayoola AS, Akioyamen NO, North WT, Charters MA. Effects of Preoperative Carbohydrate-rich Drinks on Immediate Postoperative Outcomes in Total Knee Arthroplasty: A Randomized Controlled Trial. J Am Acad Orthop Surg. 2022 Jun 1;30(11):e833-e841. doi: 10.5435/JAAOS-D-21-00960. Epub 2022 Mar 18.
PMID: 35312650DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Charters, MD
Henry Ford Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Research assistant who is not involved in any of the patients clinical care is responsible for randomization collection of data. All others are blinded to the groups involved.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, MD, Adult Joint Reconstruction
Study Record Dates
First Submitted
October 31, 2017
First Posted
December 21, 2017
Study Start
July 15, 2017
Primary Completion
August 1, 2019
Study Completion
August 1, 2019
Last Updated
February 17, 2020
Record last verified: 2020-02