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临床试验/NCT06897696
NCT06897696已完成4 期

Effect of Dexmedetomidine and Total Intravenous Anesthesia on Endothelial Damage-Related Biomarkers

Firat University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年4月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
endothelial damage in patients under general anaesthesia

研究概览

简要总结

This study aimed to evaluate whether dexmedetomidine has a protective effect on endothelial damage by measuring plasma syndecan1 and heparan sulphate levels in rhinoplasty patients who take propofol+remifentanyl infusion.

详细描述

Endothelial Glycocalyx (EG) is a carbohydrate-rich network covering the apical surface of endothelial cells. It consists of sulphated glycoproteins linked to sialic acids (heparan sulphate, dermatan sulphate), core proteoglycans (mainly syndecan-1) and unsulphated glycosaminoglycans (CD 44) directly attached to the cytoplasmic membrane of endothelial cells. The fragile nature of endothelial glycocalyx makes it highly susceptible to damage, especially in critical diseases such as septic shock and inflammation, ischaemia-reperfusion (IR) syndrome, oxidative stress and major trauma. Endothelial glycocalyx damage worsens the patient's clinical outcome, leading to capillary leakage, tissue oedema, immune system disorders, and thrombosis.

Despite the widespread use of transmission electron microscopy, fluorescence microscopy and intravital microscopy in experimental investigations, these methods are not applicable at the bedside. The second most widely used method to investigate endothelial glycocalyx is biochemical analysis of EG degradation products (e.g. syndecan-1, heparan sulphate, hyaluronan).

In surgical procedures, general anaesthesia is a pharmacological method used to control pain and consciousness. The agents administered in this process may be associated with both hypnotic and analgesic mechanisms acting on the central nervous system and side effects on the autonomic nervous system and circulatory system. Pharmacological agents used during general anaesthesia may exert pro-inflammatory or anti-inflammatory effects on the endothelium directly or indirectly. Some anaesthesia modalities may trigger endothelial damage by increasing oxidative stress, free radical production and the release of inflammatory cytokines. On the other hand, some techniques may show endothelial protective properties; this is related to the dose, duration and pharmacodynamic properties of the agents used. Because there is no pharmacological agent to prevent EG damage, it is important to prevent EG degradation in patients undergoing surgery. For all these reasons, evaluating the effects of general anaesthesia on endothelial function may provide important information for the protection of vascular health during and after surgery.

This study aimed to evaluate whether dexmedetomidine has a protective effect on endothelial damage in rhinoplasty patients under general anaesthesia by measuring plasma syndecan1 and heparan sulphate levels.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients between the ages of 18-50 who will undergo rhinoplasty will be included in the study -

排除标准

  • •patients who do not agree to participate in the study, patients with underlying peripheral arterial disease, coronary artery disease, hypertension, diabetes mellitus, and ASA (American Society of Anaesthesiologists) Classification ≥3 will be excluded.

研究组 & 干预措施

propofol+remifentanil

Active Comparator

to maintain anesthesia and analgesia propofol 5-8 mg/kg/h and remifentanil 5-10 µg/kg/h will be administered to all patients

干预措施: propofol+remifentanyl group (Drug)

dexmedetomidine+propofol+remifentanyl group

Active Comparator

The dexmedetomidine+TIVA group will receive a bolus of 0.8-1 µg/kg dexmedetomidine for 10 minutes followed by continuous dexmedetomidine infusion at a rate of 0.3-0.5 µg/kg/hour.

干预措施: Dexmedetomidine+propofol+remifentanyl group (Drug)

结局指标

主要结局

endothelial damage in patients under general anaesthesia

时间窗: from preoperative 24 hours to postoperative 24 hours

The relationship between increased serum Syndecan-1 and Heparan Sulfate levels and endothelial damage in patients under general anaesthesia

次要结局

  • dexmedetomidine protection against endothelial damage(from preoperative 24 hours to postoperative 24 hours)

研究者

发起方
Firat University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gulsum Altuntas

Faculty Member

Firat University

研究点 (1)

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