Effect of Early Postoperative Oral Carbohydrate on Postoperative Recovery of the Unilateral Knee Arthroplasty: a Randomized, Single-blind, Parallel-controlled, Multicenter Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 672
- 主要终点
- Insulin resistance index at fasting
研究概览
简要总结
To evaluate the effect of early postoperative oral carbohydrate on postoperative recovery of the unilateral knee arthroplasty
详细描述
Currently, most clinical studies on the impact of oral carbohydrates on postoperative recovery are focused on the preoperative stage, with only a few small sample studies indicating that postoperative oral carbohydrates can improve patient comfort. Orthopedic surgery, especially joint surgery, requires patients to start functional exercise as soon as possible after surgery. Joint replacement surgery requires reducing the consumption of muscle tissue caused by protein breakdown. Perioperative nutritional support for patients is of great significance for postoperative muscle function recovery and good functional exercise. However, further systematic research on the impact of early postoperative oral carbohydrates on postoperative recovery is still lacking.
This study selected patients who underwent unilateral total knee arthroplasty or single condylar arthroplasty. All surgical patients undergo homogenized preoperative preparation and intraoperative anesthesia management. Eligible patients were screened before surgery, and an informed consent form was signed. Patients enrolled in the experiment were randomly assigned into one of the three groups. They are the early feeding group (EOF1, EOF2group) and the late feeding group （control group）. Evaluate the effectiveness and safety of early postoperative feeding （EOF） in orthopedic surgery patients by measuring indicators such as insulin resistance index, QoR-15, and prealbumin and retinol binding protein.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-79 years.
- •Patients undergoing unilateral total knee arthroplasty or unicondylar joint replacement.
- •Normal diet.
- •ASA grade I~Ⅲ;
- •BMI 18-30kg /m
- •No intraspinal anesthesia contraindications.
排除标准
- •Preoperative existence of gastric emptying disorders, such as gastrointestinal obstruction, gastroesophageal reflux, or previous gastrointestinal surgery.
- •Patients with diabetes mellitus, severe renal dysfunction, or other severe metabolic diseases.
- •History of motion sickness.
- •Mental disorder, alcoholism, or a history of substance abuse.
- •Patients with abnormal swallowing function.
- •The operation time is greater than 3 hours.
- •Maltodextrin fructose allergy or intolerance.
结局指标
主要结局
Insulin resistance index at fasting
时间窗: 1 day after surgery
In the venous blood in an early morning fasting state, the change in the insulin resistance index can reflect whether the carbohydrate administration is favorable in the early postoperative period.
次要结局
- Incidence of reflux aspiration and hypoxemia(24 hours after surgery)
- The incidence and severity of various adverse events （AE） from the start of oral carbohydrates until the end of the trial(Up to 48 hours postoperative)
- Insulin resistance index at fasting(3 days after surgery)
- Incidence of postoperative nausea and vomiting(Up to 48 hours postoperative)
- The extent of the postoperative pain(Up to 48 hours postoperative)
- Patient satisfaction score(Up to 48 hours postoperative)
- The 15-item recovery quality rating scale （QoR-15）(Up to 48 hours postoperative)
- The NRS score for the thirst thirst and hunger.(2 hours, 6 hours and 8 hours after surgery)
- Pre albumin levels and retinol binding protein levels(on the day of surgery, 1 day and 3 days after surgery.)
- The degree of abdominal distension(24 hours after surgery)
- Anal exhaust time(Up to 48 hours postoperative)
- Hospitalization time(Up to 7days postoperative)
- Number of antiemetic uses(Up to 24 hours after the first start of drug administration.)
研究者
Hongwei Shi
Director, Department of Anesthesiology
Nanjing First Hospital, Nanjing Medical University