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临床试验/NCT05603364
NCT05603364进行中(未招募)1 期

Effect of Postoperative Oral Carbohydrate Administration in Total Knee Arthroplasty Elderly Patients

Nanjing First Hospital, Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2022年11月22日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
64
试验地点
1
主要终点
Pre-albumin levels at fasting

研究概览

简要总结

To evaluate the effects of early oral carbohydrates after TKA on nutritional status, comfort and safety in elderly patients.

详细描述

Most of the current clinical studies of oral carbohydrate effects on postoperative recovery focus on the preoperative oral phase, and only a few small samples have shown that postoperative oral carbohydrate improves postoperative comfort. Therefore, further systematic studies on the effects of early postoperative oral carbohydrates on postoperative recovery remain lacking.

This clinical study uses a single center, randomized, single-blind, parallel controlled trial design divided into screening, treatment and follow-up period.

Actively control blood pressure, blood pressure and blood sugar, correct anemia and hypoproteinemia, and increase protein intake before surgery. The dietary plan was informed by the ward nurse: all patients were fasted with solid food 6 hours before surgery and took 200 milliliters of carbohydrates orally 2-3 hours before surgery.

The venous access was open after home invasion and was routinely monitored electrocardiogram (ECG), non-invasive blood pressure (NBP) ,oxygen saturation (SpO2) ,bispectral index (BIS). Parecoxib 40 milligrams of analgesia was given intravenously at 30 minutes before the start of the procedure. Adductor canal block (ACB) and Infiltration between popliteal artery and capsule of knee (IPACK) block were performed on the lower limbs of the surgical side using an ultrasound high-frequency line array probe before induction of the general anesthesia procedure.

Anesthesia induction: after static injection of Midazolam 0.03 milligrams / kilogram, Propofol 2 milligrams / kilogram, Sufentanyl 0.4 milligrams / kilogram, Cisatracurium 0.2 milligrams / kilogram. The tracheal tube was inserted after 3minutes and mechanical controlled ventilation was performed mechanical controlled ventilation, fraction of inspired oxygen(FiO2) 40%, oxygen flow 2 liters/ minutes, minute ventilation 7 milliliters / kilogram, respiratory rate(RR)12 times/ inspiration-to-expiratory ratio(I: E)1:2, maintain partial pressure of carbon dioxide in end expiratory gas (PETCO2) 35-40 millimeters of mercury(mmHg). Anesthesia maintenance: intravenous propofol 4~7 milligrams / kilogram/ hour, remifentanil 0.3-0.5micrograms /kilogram/ hour, maintain BIS 40~60. A restrictive fluid management strategy was adopted, with 6ml/ kg·h supplemented with physiological needs, blood loss was supplemented with hydroxyethyl starch fluid, and concentrated red blood cells were infused at hemoglobin (Hb) <80 grams / litre to maintain patient blood pressure and heart rate fluctuations less than ±20% of the basal value. Dexamethasone 5mg and Tropisetron 2mg for prophylactic antiemesis were given intravenously at 30min before the end of the surgery. All patients used hydromorphone patient-controlled intravenous analgesia(PCIA ) pump for continuous: 1ml / h, automatic control: 5ml, locking: 10min, limit: 35ml / h, adjust parameters according to the pain.

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients undergoing elective knee replacement surgery.
  • •The patient gave informed consent.
  • •Age ≥65 years, Sex is not limited
  • •American Society of Anesthesiologists (ASA)Ⅰ~Ⅲ level
  • •Body Mass Index (BMI)18~28kg/m2

排除标准

  • •Preoperative gastric emptying disorders, such as gastroesophageal reflux or previous surgery.
  • •Diabetes mellitus, severe renal insufficiency, or other severe metabolic diseases.
  • •History of motion sickness.
  • •Mental disorders, alcoholism, or a history of substance abuse.
  • •Patients with abnormal swallowing function.
  • •Maltodextrin, fructose allergy or intolerance.
  • •Surgery time was greater than 3 hours.

研究组 & 干预措施

EOF group:early carbohydrate feeding

Experimental

The EOF group drank 10.5% of 5 ml/kg body weight (100ml containing 12.5g maltodextrin, fructose and glucose) after extubation in the resuscitation room.

干预措施: 100ml carbohydrate containing 12.5g maltodextrin, fructose and glucose (Combination Product)

Control group:conventional feeding

Experimental

Patients in group C were observed with 60minutes of abnormal vital signs after extubation, and returned to the ward for fasting and fasting for at least 6 hours, and began to eat gradually through the mouth after anal exhaust.

干预措施: Routine feeding (Other)

结局指标

主要结局

Pre-albumin levels at fasting

时间窗: 1 day after surgery

The change in prealbumin levels in venous blood in a fasting state in the early morning can reflect whether carbohydrate administration is favorable in the early postoperative period

次要结局

  • Pre-albumin levels at fasting(3 days after surgery)
  • Retinol-binding protein levels at fasting levels(Analyzed in early morning fasting venous blood samples at 3 time points: Operatively (day 0), postoperatively(day1), postoperatively(day3))
  • Insulin resistance index at fasting(Analyzed in early morning fasting venous blood samples at 3 time points: Operatively (day 0), postoperatively(day1), postoperatively(day3))
  • The NRS score for the thirst condition(2 hours, 6 hours and 8 hours after surgery)
  • Time of first ambulation after surgery(Up to 48 hours postoperative)
  • The incidence of reflux aspiration(24 hours after surgery)
  • The incidence rate of hypoxemia(24 hours after surgery)
  • Patient satisfaction score(Up to 48 hours postoperative)
  • 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)
  • The incidence and severity of adverse events such as nausea, vomiting and hypoxemia from the first start of drug administration until the end of the trial;(Up to 48 hours postoperative)
  • Number of antiemetic drugs used within 24h of initial administration until the first start of administration(Up to 24 hours postoperative)
  • The NRS score for the starvation conditions(2 hours, 6 hours and 8 hours after surgery)
  • The degree of abdominal distension(24 hours after surgery)
  • Time of the first anal exhaust after surgery(Up to 48 hours postoperative)
  • length of patient stays(Up to 7days postoperative)
  • Pre-albumin levels at fasting(On the day of the surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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