NCT06897696

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 27, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

April 10, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

March 13, 2025

Last Update Submit

January 1, 2026

Conditions

Endothelial DamageDexmedetomidineSyndecan 1Heparan Sulpahate

Outcome Measures

Primary Outcomes (1)

  • endothelial damage in patients under general anaesthesia

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

    from preoperative 24 hours to postoperative 24 hours

Secondary Outcomes (1)

  • dexmedetomidine protection against endothelial damage

    from preoperative 24 hours to postoperative 24 hours

Study Arms (2)

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

Drug: propofol+remifentanyl group

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.

Drug: Dexmedetomidine+propofol+remifentanyl group

Interventions

Dexmedetomidine+propofol+remifentanyl groupDRUG

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.

dexmedetomidine+propofol+remifentanyl group
propofol+remifentanyl groupDRUG

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

propofol+remifentanil

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Firat University Hospital

Elâzığ, 23100, Turkey (Türkiye)

Location

Study Officials

  • Gulsum Altuntas

    Firat University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty Member

Study Record Dates

First Submitted

March 13, 2025

First Posted

March 27, 2025

Study Start

April 10, 2025

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

January 6, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

study protocol will be shared with other researchers

Shared Documents
STUDY PROTOCOL
Time Frame
from 2025 december
Access Criteria
all researchers

Locations

TU(1)