Effects of Different Preoperative Oral Rehydration Protocols on Safety, Comfort, and Postoperative Outcomes in Elderly Patients Undergoing Thoracoscopic Radical Lung Cancer Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 420
- 主要终点
- postoperative delirium
研究概览
简要总结
This study aims to compare the new preoperative oral rehydration protocol (administering 50-100 mL of clear fluids or carbohydrate-rich beverages orally every hour until the patient arrives at the operating room) with the traditional preoperative protocol (consuming 200-300 mL of water orally two hours prior to surgery). The objective is to investigate the effects of these two protocols on the safety (e.g., risk of reflux and aspiration), comfort (e.g., levels of hunger, thirst, and anxiety), gastric emptying status (as assessed by gastric ultrasound indicators), and postoperative outcomes (e.g., incidence of postoperative delirium, insulin resistance, and inflammatory factor levels) in elderly patients undergoing thoracoscopic lung cancer radical surgery. This research seeks to identify a more appropriate preoperative rehydration protocol for elderly lung cancer patients.
详细描述
This study employed a randomized controlled double-blind trial, including 420 elderly patients (aged 65 and above) who were scheduled to undergo thoracoscopic lung cancer radical surgery. The efficacy of three preoperative oral rehydration regimens was compared. The control group orally consumed 200-300ml of clear water 2 hours before the operation; the intervention group 1 orally consumed 50-100ml of clear water every hour before the operation; the intervention group 2 orally consumed 50-100ml of 12.5% carbohydrate beverages every hour before the operation, all requiring to be consumed slowly within 10-15 minutes. The evaluation indicators included: safety (intraoperative reflux aspiration, postoperative nausea and vomiting, incision and pulmonary infection rates), gastric ultrasound (amount of fluid in the stomach and emptying time), comfort (VAS for assessing hunger and thirst, SAS for assessing anxiety), postoperative delirium (CAM scale combined with electroencephalogram), insulin resistance (FPG, FINS, and HOMA-IR), and inflammatory factors (Interleukin-6, Tumor necrosis factor -α, C-reactive protein). The research data were analyzed using SPSS software to clarify the impact of different rehydration regimens on elderly patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elderly patients aged 65 or above who are scheduled to undergo thoracoscopic radical lung cancer surgery.
- •American Society of Anesthesiologists (ASA) classification levels II-III.
- •No severe cognitive impairment (Mini-Mental State Examination (MMSE) score ≥ 24).
- •Able to cooperate with the study and sign the informed consent form.
排除标准
- •Combined with severe functional impairments of important organs such as the heart, liver, and kidneys.
- •Suffering from metabolic diseases such as diabetes and hyperthyroidism.
- •Having digestive system diseases such as gastric emptying disorders, dysphagia, and intestinal obstruction.
- •Allergic or intolerant to carbohydrates.
- •Had received treatments such as radiotherapy and chemotherapy before the surgery that might affect the research indicators.
- •Patients with mental disorders or cognitive dysfunction.
结局指标
主要结局
postoperative delirium
时间窗: One to three days after the operation
The Confusion Assessment Method - Short Form(CAM-S) scoring for postoperative delirium is as follows: Total score 20 points, 0-6 points :Mild delirium; 7-12 points:Moderate delirium; ≥13 points: Severe delirium.
preoperative anxiety
时间窗: One day before the operation and in the morning of the operation
The Generalized Anxiety Disorder-7 (GAD-7) scale for preoperative anxiety assessment is as follows:Total score: 21 points，0-4 points: Normal，5-9 points: Mild anxiety，10-14 points: Moderate anxiety，≥15 points: Severe anxiety.
The amount of fluid in the stomach
时间窗: 2 hours before the operation, 1 hour before the operation, and before anesthesia induction
Ultrasound examination of the cross-sectional area of the antrum of the stomach
insulin resistance
时间窗: on the early morning of the day before the operation,the first day and the third day after operation
venous blood was collected from the patients to detect fasting plasma glucose (FPG), insulin (FINS), and homeostasis model assessment of insulin resistance index (HOMA-IR).
次要结局
- Perioperative hunger(2 hours and 1 hour before the operation, before anesthesia induction and 6 hours after the operation)
- Perioperative thirst(2 hours and 1 hour before the operation, before anesthesia induction and 6 hours after the operation)
- The incidence of reflux aspiration during the perioperative period(During the operation and 3 days after the operation)
- The incidence of perioperative nausea and vomiting(During the operation and 3 days after the operation)
- C-reactive protein(on the early morning of the day before the operation,the first day and the third day after operation)
- Tumor necrosis factor -α(on the early morning of the day before the operation,the first day and the third day after operation)
- Interleukin-6(on the early morning of the day before the operation,the first day and the third day after operation)