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临床试验/NCT03380754
NCT03380754已完成不适用

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

Henry Ford Health System2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
2
主要终点
Post operative nausea

研究概览

简要总结

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.

详细描述

Postoperative nausea and vomiting (PONV) continues to pose serious challenge to orthopaedic adult reconstructive surgeons, even after recent advances in anesthesia and improvements in perioperative care. Preoperative carbohydrate loading has been well studied in non-arthroplasty surgical fields. It has been shown to benefits which include decreased postoperative catabolism and insulin resistance, dampened metabolic stress response, thus decreased postoperative pain, anxiety, nausea, and vomiting. To the investigators knowledge, there is currently no literature describing the effects of preoperative carbohydrate rich drinks (CHO) in the setting of elective total joint arthroplasty. Using a prospective, randomized, double blind, placebo controlled model, the investigators aim to determine the effect of CHO on PONV in total knee arthroplasty.

The investigators plan to include a total of 150 patients in this study. All the arthroplasty surgeons at HF Main Campus expect to participate. Estimating approximately 20 patients enrolled per month, enrollment would likely occur over time span of 8 months.

Patients who are scheduled for elective, primary total knee arthroplasty will be recruited and consented in preoperative clinic visit according to the inclusion and exclusion criteria as outlined. Screening and consenting will be performed by the orthopaedic surgeon, resident, physician assistant, or nurse practitioner in clinic, who will be trained for this study. Patients who elect to participate will be randomized to CHO drink (Group A), placebo drink (Group B), or traditional fasting/no drink (Group C). Randomization will occur prior to enrollment in batches of twenty. Patients and treatment team will be blinded to the assignment. Enrolled subjects will be given a kit which will include study information, instructions for participation, data collection questionnaire (included with this submission), multiple-alarm timer, and two beverage bottles (labeled Drink 1 and Drink 2) for those in Group A or B. Group C will receive the kit, but without beverage. A research assistant who is not involved in any of the subjects' care will be responsible for preparation of the kits.

Beverage in Group A will consist of a clear, non-carbonated lemon-flavored, iso-osmolar carbohydrate drink (Nutricia preOp; 12.5% carbohydrates, 50kcal/100mL, 260mOsm/kg, pH 5.0). This drink has been previously used in studies supporting Enhanced Recovery After Surgery (ERAS) Society Consensus Guidelines. Beverage in Group B will consist of the same quantity of clear, lemon flavored water (Nestle Splash Lemon; 0kcal/100mL). All beverages will be bottled in clear PET plastic IPEC tamper evident bottles. Bottles will be labeled Drink 1 (800 mL) or Drink 2 (400 mL). Neither subjects nor treatment team will be able to identify type of beverage, however each drink label will include a special code, available only to research assistant to be able to identify contents of bottle (treatment vs placebo).

During the evening before surgery (8:00-10:00 PM), subjects in Group A and B will consume Drink 1 (800 mL) of their respective drink. After midnight, nothing will be allowed by mouth, except for except for single morning dose of appropriate drink (Drink 2, 400 mL) in Group A and Group B. Subjects will be instructed to consume morning drink 3 hours prior to scheduled time of surgery, and be completely consumed at least 2 hours prior to surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Post operative nausea

时间窗: 24 hours postoperatively

Nausea, assess by questionnaire, 10 point scale (0 = no nausea, 10 = very nauseous, and medical record.

Post operative vomiting

时间窗: 24 hours postoperatively

Vomiting, assess by questionnaire, 10 point scale (0 = no vomiting, 10 = copious emesis, and medical record notes of emesis.

次要结局

  • Incidence of secondary adverse events(From the time of surgery until the time of hospital discharge, assessed up to 1 month postoperatively)
  • Post operative opiate consumption(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)
  • 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 pain scores(From the time of surgery until the time of hospital discharge, assessed up to 72 hours postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Charters, MD

Principal Investigator, MD, Adult Joint Reconstruction

Henry Ford Health System

研究点 (2)

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