Intravenous Dexmedetomidine as a Perioperative Autonomic-Immune Neuromodulator in Total Hip Arthroplasty: a Randomized Double-Blind Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in the Systemic Immune-Inflammation Index (SII)
研究概览
简要总结
Surgical trauma induces activation of the sympathetic nervous system and triggers a systemic inflammatory response that may adversely affect postoperative recovery. Dexmedetomidine, a highly selective α2-adrenoceptor agonist, has been proposed as a pharmacological neuromodulatory strategy capable of attenuating sympathetic activation and modulating neuroimmune interactions during the perioperative period. However, the extent to which intravenous dexmedetomidine influences perioperative inflammatory biomarkers and clinical recovery in patients undergoing total hip arthroplasty under regional anesthesia remains unclear.
This prospective, randomized, double-blind, placebo-controlled trial aims to evaluate the effects of two doses of intravenous dexmedetomidine administered during spinal anesthesia combined with ultrasound-guided pericapsular nerve group (PENG) block on autonomic regulation, systemic inflammatory response, postoperative pain, opioid consumption, and quality of recovery following elective primary total hip arthroplasty.
详细描述
Total hip arthroplasty is associated with substantial surgical stress resulting in activation of the sympathetic nervous system, neuroendocrine stress pathways, and systemic inflammation. Excessive perioperative autonomic activation contributes to inflammatory dysregulation, postoperative pain, opioid requirements, delayed functional recovery, and postoperative complications. Strategies capable of attenuating this autonomic stress response may therefore improve postoperative outcomes beyond conventional analgesia.
Dexmedetomidine is a highly selective α2-adrenoceptor agonist with sedative, analgesic, sympatholytic, and anti-inflammatory properties. Experimental and clinical evidence suggests that intravenous dexmedetomidine may reduce sympathetic outflow, attenuate neuroendocrine stress responses, modulate cytokine release, and preserve autonomic homeostasis during the perioperative period. Nevertheless, prospective randomized studies evaluating its effects on both autonomic regulation and systemic inflammatory response in patients receiving contemporary regional anesthesia remain limited.
This prospective, randomized, double-blind, placebo-controlled trial will compare three perioperative strategies in patients undergoing elective primary total hip arthroplasty under spinal anesthesia combined with ultrasound-guided PENG block:
placebo, low-dose intravenous dexmedetomidine, high-dose intravenous dexmedetomidine. All patients will receive identical surgical, anesthetic, and multimodal analgesic management. Intravenous dexmedetomidine administration will constitute the only study intervention.
The primary objective is to determine whether intravenous dexmedetomidine attenuates the perioperative systemic inflammatory response as assessed by changes in the Systemic Immune-Inflammation Index (SII). Secondary objectives include evaluation of additional inflammatory biomarkers including neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), C-reactive protein (CRP), monocyte-to-lymphocyte ratio (MLR), Systemic Inflammation Response Index (SIRI), and Aggregate Index of Systemic Inflammation (AISI), together with perioperative hemodynamic stability, vasopressor requirements, postoperative pain intensity, opioid consumption, time to first rescue analgesia, quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire, postoperative nausea and vomiting, time to first ambulation, length of hospital stay, patient satisfaction, and postoperative complications.
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
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 50-90 years.
- •Scheduled for elective primary total hip arthroplasty due to primary hip osteoarthritis.
- •American Society of Anesthesiologists (ASA) physical status I-III.
- •Planned spinal anesthesia combined with ultrasound-guided Pericapsular Nerve Group (PENG) block.
- •Ability to understand the study procedures and provide written informed consent.
排除标准
- •Refusal to participate or inability to provide written informed consent.
- •Contraindications to spinal anesthesia.
- •Contraindications to PENG block.
- •Allergy or hypersensitivity to dexmedetomidine, ropivacaine, bupivacaine, or study medications.
- •Second- or third-degree atrioventricular block without a permanent pacemaker.
- •Resting heart rate <50 beats/min.
- •Severe hepatic impairment (Child-Pugh class C).
- •Severe renal failure requiring dialysis.
- •Chronic opioid therapy (>3 months before surgery).
- •Chronic treatment with α2-adrenergic agonists.
- •Cognitive impairment or inability to complete postoperative questionnaires.
- •Infection at the injection site.
- •Coagulopathy or ongoing anticoagulation precluding neuraxial anesthesia according to current guidelines.
- •Revision total hip arthroplasty.
- •Simultaneous bilateral total hip arthroplasty.
- •Participation in another interventional clinical trial within the previous 30 days.
结局指标
主要结局
Change in the Systemic Immune-Inflammation Index (SII)
时间窗: 24 24 hours after surgery
Comparison of the change in the Systemic Immune-Inflammation Index (SII) from baseline to 24 hours after surgery among the three study groups.
次要结局
- Change in Systemic Immune-Inflammation Index (SII)(12 hours after surgery)
- Change in Systemic Immune-Inflammation Index (SII)(48 hours after surgery)
- Neutrophil-to-Lymphocyte Ratio (NLR)(12 hours after surgery)
- Neutrophil-to-Lymphocyte Ratio (NLR)(24 hours after surgery)
- Neutrophil-to-Lymphocyte Ratio (NLR)(48 hours after surgery)
- Platelet-to-Lymphocyte Ratio (PLR)(12 hours after surgery)
- Platelet-to-Lymphocyte Ratio (PLR)(24 hours after surgery)
- Platelet-to-Lymphocyte Ratio (PLR)(48 hours after surgery)
- C-reactive protein (CRP)(24 hours after surgery)
- Postoperative opioid consumption(48 hours after surgery)
- Time to first rescue opioid analgesia(48 hours after surgery)
- QoR-15(24 hours after surgery)
- QoR-15(48 hours after surgery)
- Postoperative pain intensity at rest(2 hours after surgery)
- Postoperative pain intensity at rest(6 hours after surgery)
- Postoperative pain intensity at rest(12 hours after surgery)
- Postoperative pain intensity at rest(24 hours after surgery)
- Postoperative pain intensity at rest(48 hours after surgery)
- Postoperative pain intensity at movement(2 hours after surgery)
- Postoperative pain intensity at movement(6 hours after surgery)
- Postoperative pain intensity at movement(12 hours after surgery)
- Postoperative pain intensity at movement(24 hours after surgery)
- Postoperative pain intensity at movement(48 hours after surgery)
- Incidence of postoperative nausea and vomiting(48 haours after surgery)
- Intraoperative vasopressor requirement(durring surgery)
- Incidence of intraoperative hypotension(durring surgery)
- Systemic Inflammation Response Index (SIRI)(24 hours after surgery)
- Systemic Inflammation Response Index (SIRI)(48 hours after surgery)
- Aggregate Index of Systemic Inflammation (AISI)(24 hours after surgery)
- Aggregate Index of Systemic Inflammation (AISI)(48 hours after surgery)