Effects of a Combined Nerve Block on Intraoperative Stress and Postoperative Immune Function in Elderly Patients Subjected to Total Hip Replacement: Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Intraoperative serum cortisol concentration
研究概览
简要总结
The purpose of this study is to validate the hypothesis that a combined nerve block produces better outcomes including intraoperative stress, hemorrheological indexes, postoperative immune function, and incidence of postoperative complications than general anesthesia.
详细描述
The elderly patients have poor tolerance to anesthesia and total hip replacement because of severe surgical trauma and much blood loss. General anesthesia is a primary anesthesia method used previously for total hip replacement in the elderly and it has many limitations, for example, it can interfere with the physiological function in the elderly patients. The organic function and compensative ability of the elderly are often weakened to varying degrees because of cardiovascular disease, pulmonary disease or diabetes mellitus, thus nociceptive stimuli such as anesthesia and surgery greatly influence the stress.
Stress refers to an organism's non-specific reactions to various nociceptive stimuli, i.e., stressors, in which many factors are involved. It can stimulate sympathetic nerves, strengthen the function of hypothalamic-pituitary-adrenal axis, and cause changes in various metabolisms, thereby playing an important role in maintaining intraoperative vital signs and recovering postoperative immune function. Different anesthesia methods produce different effects on organism's immune function. Effects of anesthesia on immune function are closely related to the complications, such as postoperative infection. In addition, the immunity in the elderly is relatively poorer than that in the normal healthy population. Therefore, a rational anesthesia method is of important clinical significance for safe surgery and postoperative recovery in the elderly. A combined nerve block has been reportedly to be more suitable for total hip replacement in the elderly because of its safety and reliability.
Previous related studies focused primarily on onset time of anesthesia and postoperative complications. To the best of our knowledge, no studies have been reported on the effect of a combined nerve block on intraoperative stress and postoperative immune function in the elderly patients subjected to total hip replacement. Therefore, this study is innovative in our mind.
Adverse events
If severe adverse events including any expected or unexpected symptoms occur, information including the data of occurrence, type of adverse events, measures taken related to the treatment of the adverse events will be reported to the project manager and the institutional review board within 24 hours.
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
- None
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
- •Blood pressure below 160/90 mmHg (1 mm = 0.133 kPa)
- •Hemoglobin > 90 g/L
- •Fasting blood glucose level < 10 mM
- •Preoperative examinations (blood, urine, stool tests, hepatic and renal function, blood coagulation, electrolyte level and electrocardiogram): normal
- •Type I-II in American Society of Anesthesiology (ASA) classification
- •Age > 65 years
- •Of either sex
- •Provision of signed informed consent to participate in the trial
排除标准
- •Severe heart, liver, lung, kidney or hematological system diseases, severe infection or malignant tumor
- •Allergy to anesthetic agents
- •Are taking immunosuppressive agents and/or glucocorticoid
- •Viral infections
- •Mental disorder, dysnoesia, hearing disorder or poor compliance during the anesthesia
- •Alcohol or drug abuse
结局指标
主要结局
Intraoperative serum cortisol concentration
时间窗: during surgery
To evaluate intraoperative stress response. The normal serum cortisol concentration is 138-635 nM measured at 8:00 a.m.-10:00 a.m. and 83-359 nM at 4:00 p.m.-6:00 p.m. Greater intraoperative serum cortisol concentration indicates stronger stress response.
次要结局
- Serum cortisol concentration(prior to anesthesia, prior to and immediately after surgery)
- Incidence of adverse events(1, 3, 7 days and 3 months after surgery)
- Blood glucose level(prior to anesthesia, prior to, during and immediately after surgery)
研究者
Liangde A
Associate Chief Physician
Qinghai University