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Completed

NCT Number: NCT06897696

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Firat University Hospital

Elâzığ, 23100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

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Treatment and study plan

Dexmedetomidine+propofol+remifentanyl group

Drug

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.

propofol+remifentanyl group

Drug

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

Primary outcomes

  1. endothelial damage in patients under general anaesthesia

    Time frame: 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

Secondary outcomes

  1. dexmedetomidine protection against endothelial damage

    Time frame: from preoperative 24 hours to postoperative 24 hours

    Difference in endothelial damage between the patients receiving dexmedetomidine and those not receiving dexmedetomidine

Sponsors and collaborators

Lead sponsor

Firat University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 27, 2025
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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