The Effect of Esketamine Combined With Dexmedetomidine on Postoperative Recovery Quality in Patients Undergoing Thoracoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Record the QoR-15 scale scores for three groups of patients before surgery, on the first day after surgery, and on the third day after surgery.
研究概览
简要总结
Brief Summary：Video-assisted thoracoscopic surgery (VATS) has a wide range of applications, including the diagnosis and treatment of lung cancer, and has gradually replaced traditional open thoracotomy. VATS must routinely employ single-lung ventilation techniques. During single-lung ventilation, mechanical injury, lung collapse, imbalance in the ventilation-perfusion ratio, ischemia-reperfusion, and other pathological physiological changes may occur, leading to the release of a large number of inflammatory factors, triggering local and systemic inflammatory responses,increasing the incidence of postoperative complications, and affecting patient outcomes. Additionally, most patients undergoing thoracoscopic surgery experience acute postoperative pain. If acute postoperative pain is not adequately controlled, it may progress to chronic pain, affecting the quality of postoperative recovery. Currently, opioid medications are the primary drugs used to treat moderate to severe postoperative pain. However, adverse events associated with opioid medications may also affect the quality of postoperative recovery.The use of multimodal analgesia for postoperative pain management can control pain and reduce the need for opioid medications.
Esketamine, a newly marketed intravenous anesthetic in China in recent years, is the dextrorotatory isomer of ketamine, and acts as a non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor. Compared to ketamine, esketamine has higher potency, faster recovery time, and fewer adverse effects. Some clinical studies have shown that administration of esketamine reduces the intensity of postoperative pain and decreases the need for postoperative analgesics. Research has found that esketamine reduces the consumption of opioid medications and hyperalgesia postoperatively. Additionally, studies have shown that esketamine administration improves recovery quality by alleviating postoperative pain. Dexmedetomidine (DEX) is a selectiveα2 adrenergic receptor agonist with sedative and analgesic effects. Studies have shown that dexmedetomidine effectively reduces surgical inflammation, oxidative stress, and postoperative pain, thereby promoting postoperative recovery in surgical patients without increasing the risk of adverse reactions or complications. A meta-analysis indicated that dexmedetomidine administration alleviates postoperative pain and reduces postoperative nausea and vomiting (PONV). Current evidence suggests that the use of dexmedetomidine improves postoperative recovery quality. However, the effects of esketamine combined with dexmedetomidine on postoperative recovery quality in patients undergoing thoracoscopic surgery have not been reported. This study aims to investigate whether the combined administration of esketamine and dexmedetomidine can further improve postoperative recovery quality in patients undergoing thoracoscopic surgery.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years old;
- •BMI 18-30 kg/m2;
- •ASA classification I-III;
- •Patients undergoing thoracoscopic surgery;
- •No contraindications to the study drug;
- •Ability to express, communicate, and understand normally;
- •Both the patient and their family members agree to participate in this study and sign the informed consent form.
排除标准
- •Patients with poorly controlled or untreated hypertension;
- •Patients with untreated hyperthyroidism;
- •Patients with mental illness, cognitive impairment, or language barriers that prevent communication;
- •Patients with severe cardiopulmonary, hepatic, or renal dysfunction;
- •Patients with increased intracranial pressure;
- •Patients with a history of allergic reactions to any of the drugs used in the study;
研究组 & 干预措施
Saline solution + dexmedetomidine group
Administer 0.5 ug/kg of dexmedetomidine 10 minutes before surgery, and maintain at 0.4 ug/kg/h after intubation until 30 minutes before the end of surgery,Administer saline solution one minute after induction of anesthesia and continue until 30 minutes before the end of surgery.
干预措施: Saline Solution (NaCl 0,9%) (Drug)
Low-dose esketamine + dexmedetomidine group
Administer dexmedetomidine 0.5 μg/kg 10 minutes before surgery, maintain at 0.4 μg/kg/h after intubation until 30 minutes before the end of surgery, administer esketamine 0.2 mg/kg 1 minute after induction of anesthesia, maintain at 2 μg/kg/min after intubation until 30 minutes before the end of surgery.
干预措施: Low-dose esketamine infusion (Drug)
High-dose esketamine + dexmedetomidine group
Administer 0.5 ug/kg of dexmedetomidine 10 minutes before surgery, and maintain at 0.4 ug/kg/h after intubation until 30 minutes before the end of surgery, Administer 0.2 mg/kg of esketamine 1 minute after induction of anesthesia, and maintain at 4 μg/kg/min after intubation until 30 minutes before the end of surgery.
干预措施: High-dose esketamine infusion (Drug)
结局指标
主要结局
Record the QoR-15 scale scores for three groups of patients before surgery, on the first day after surgery, and on the third day after surgery.
时间窗: Record the QoR-15 scale scores for three groups of patients before surgery, on the first day after surgery, and on the third day after surgery.
次要结局
未报告次要终点
研究者
Jinqiao Qian
professor
First Affiliated Hospital of Kunming Medical University