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Effects of Preoperative Carbohydrate Rich Drinks on Immediate Postoperative Outcome in Total Knee Arthroplasty (PONV)

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ClinicalTrials.gov Identifier: NCT03380754
Recruitment Status : Recruiting
First Posted : December 21, 2017
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Charters, MD, Henry Ford Health System

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.

Condition or disease Intervention/treatment Phase
Post Operative Nausea and Vomiting Dietary Supplement: Nutricia preOp Other: Nestle Splash Lemon Flavor Water (Placebo) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, double blinded, placebo controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
Official Title: Effects of Preoperative Carbohydrate Rich Drinks on Immediate Postoperative Outcome in Total Knee Arthroplasty
Actual Study Start Date : July 15, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Carbohydrate Rich Drink
Group A will receive the carbohydrate rich drink, Nutricia preOp. This is the intervention group.
Dietary Supplement: Nutricia preOp
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.
Other Name: Carbohydrate rich drink

Placebo Comparator: Placebo Drink
Group B will receive placebo, Nestle Splash Lemon Flavor Water (Placebo) (similarly flavored and appearing water, however with no calorie, carbohydrate or nutritional content).
Other: Nestle Splash Lemon Flavor Water (Placebo)
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.

No Intervention: No Drink
Group C will not receive any drink. This group will follow normal protocol.



Primary Outcome Measures :
  1. Post operative nausea [ Time Frame: 4 hours postoperatively ]
    Nausea, assess by questionnaire, 10 point scale (0 = no nausea, 10 = very nauseous, and medical record.

  2. Post operative nausea [ Time Frame: 12 hours postoperatively ]
    Nausea, assess by questionnaire, 10 point scale (0 = no nausea, 10 = very nauseous, and medical record.

  3. Post operative nausea [ Time Frame: 24 hours postoperatively ]
    Nausea, assess by questionnaire, 10 point scale (0 = no nausea, 10 = very nauseous, and medical record.

  4. Post operative vomiting [ Time Frame: 4 hours postoperatively ]
    Vomiting, assess by questionnaire, 10 point scale (0 = no vomiting, 10 = copious emesis, and medical record notes of emesis.

  5. Post operative vomiting [ Time Frame: 12 hours postoperatively ]
    Vomiting, assess by questionnaire, 10 point scale (0 = no vomiting, 10 = copious emesis, and medical record notes of emesis.

  6. Post operative vomiting [ Time Frame: 24 hours postoperatively ]
    Vomiting, assess by questionnaire, 10 point scale (0 = no vomiting, 10 = copious emesis, and medical record notes of emesis.


Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: From the time of hospital admission following surgery, until the time of hospital discharge as recorded in EMR, assessed up to 1 month ]
    Length of stay recorded in hours

  2. Post operative opiate consumption [ Time Frame: From the time of surgery until the time of hospital discharge, assessed up to 72 hours postoperatively ]
    Morphine equivalents, opiates assessed by medical record

  3. Post operative pain scores [ Time Frame: From the time of surgery until the time of hospital discharge, assessed up to 72 hours postoperatively ]
    Pain, 10 point visual analog pain scale (0 = no pain, 10 = worst pain ever)

  4. Peri operative hunger and discomfort [ Time Frame: 4 hours, 12 hours, and 24 hours postoperatively ]
    Hunger and discomfort, 10 point hunger scale (0 = satiated and comfortable, 10 = very hungry and uncomfortable)

  5. Incidence of secondary adverse events [ Time Frame: From the time of surgery until the time of hospital discharge, assessed up to 1 month postoperatively ]
    pulmonary aspiration, delay of surgery due to consumption of drink.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult patients (>18 years of age) scheduled for elective, unilateral, primary total knee arthroplasty
  • Able to give valid consent

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380754


Contacts
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Contact: Allen A Kadado, MD 2489900410 akadado1@hfhs.org

Locations
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United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Allen A Kadado, MD    248-990-0410    akadado1@hfhs.org   
Sponsors and Collaborators
Henry Ford Health System
Investigators
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Principal Investigator: Michael Charters, MD Henry Ford Hospital

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Responsible Party: Michael Charters, MD, Principal Investigator, MD, Adult Joint Reconstruction, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT03380754     History of Changes
Other Study ID Numbers: 11180
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: There are currently no plans to share participant data with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Michael Charters, MD, Henry Ford Health System:
Nausea
Vomiting
Knee Arthroplasty
PONV
TKA

Additional relevant MeSH terms:
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Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes