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Clinical Trials/NCT06897696
NCT06897696CompletedPhase 4

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

Firat University1 site in 1 country90 target enrollmentStarted: April 10, 2025Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
90
Locations
1
Primary Endpoint
endothelial damage in patients under general anaesthesia

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

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

Intervention: 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.

Intervention: Dexmedetomidine+propofol+remifentanyl group (Drug)

Outcomes

Primary Outcomes

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

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

Investigators

Sponsor
Firat University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gulsum Altuntas

Faculty Member

Firat University

Study Sites (1)

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