Effect of Preoperative Oral Carbohydrate Loading on Elderly Patient Quality of Recovery in Total Knee Arthroplasty: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Quality of Recovery-15 score
研究概览
简要总结
This prospective randomized controlled study will be aimed to evaluate the effect of preoperative oral carbohydrate loading on the elderly patient's quality of recovery and satisfaction in undergoing knee arthroplasty (TKA) surgery with spinal anesthesia.
详细描述
As an essential aspect of enhanced recovery after surgery, the advantages of preoperative oral carbohydrate loading (eg, improving patients' comfort during preoperative preparation, reducing nausea and vomiting, and reducing insulin resistance) have been shown by a large number of studies.
This study will be conducted as a single-center, prospective, randomized, double-blinded trial in a university hospital. Elderly ( > 65) patients scheduled for elective TKA will be screened for enrollment in the study. Patients will be randomized into an oral carbohydrate group (Group OC), and an oral placebo group (Group OP). Solid food will be forbidden starting at 20:00, and drinking will be banned after 22:00 the day before surgery. Oral carbohydrate preload will be administered to the Group OC. In Group OP, the blinded researcher will give an equal volume of placebo fluid orally at 22:00 and 2 hours before the operation in the ward. The participant will record that the liquid has been completely consumed
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Physical status according to the American Society of Anesthesiologists (ASA) I-III
- •Patients scheduled for total knee arthroplasty
排除标准
- •Previous operation on same knee
- •Hepatic or renal insufficiency
- •Younger than 65 years old
- •Patients undergoing general anesthesia
- •Allergy or intolerance to one of the study medications
- •Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
- •Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent of >5mg/day for one month)
- •impaired gastrointestinal motility
- •Fasting glucose >200
- •Acquired immunodeficiency
- •Severe malnutrition
结局指标
主要结局
Quality of Recovery-15 score
时间窗: Postoperative 24th hour
Minimum value: 0, Maximum value: 150, higher scores mean better.
次要结局
- Quality of Recovery-15 score(preoperative, postoperative day 7)
- Numerical Rating Scale(24 hours)
- Opioid consumption(24 hours)
- Patient mobilization(48 hours)
- Patient well-being (thirst, hunger, mouth dryness, nausea and vomiting, fatigue) will be assessed just before the operating room admission(preoperative)
- Sleep Quality measured with Likert Scale(One week after surgery)
- Range of knee motion(48 hours)
- Glucose measurement(Postoperative 24th hour)
- Mini Mental State Examination(preoperative and postoperatve day 1)