Effects of Dexmedetomidine on Intraocular Pressure During Scheduled Spine Surgeries
NCT ID: NCT04628663
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2021-03-20
2026-05-31
Brief Summary
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Detailed Description
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The patients will be randomized with closed envelope manner into two groups: the group of dexmedetomidine and the group of normal saline.
In the dexmedetomidine group (DEX group), bolus dose 1,0 μg/kg of dexmedetomidine will be administered in 10min before induction to anesthesia and 0,4-0,8 μg/kg/h of dexmedetomidine will be infused continuously until the end of the surgery.
In the saline group (placebo group), the same volume of saline will be administered in an identical way.
All study medication will be prepared by an independent anesthesiologist who is not associated in the study (who will hold the randomization codes until the end of the study).
All patients will receive the same type of anaesthesia (TIVA with propofol) and postoperative analgesia including paracetamol 1gr iv (4 times/day) and continuous wound infiltration with ropivacaine 0.2% 5ml/h for 48 postoperative hours.
Basic monitoring for the study includes:
ECG, Invasive and noninvasive blood pressure, Heart Rate, EtCO2, SpO2, Cardiac Output (CO), Stroke Volume (SV), Stroke Volume Variation (SVV), Patient State index (PSi), IOP, Urine output.
Measurements
The measurement of IOP will be conducted in both eyes with Icare PRO tonometer by an ophthalmologist who will not know in which group the patient is in the below predefined time points:
* T1: before administration of the study drug
* T2: after administration of the bolus dose of the study drug
* T3: after tracheal intubation
* T4: just before prone position
* T5: just after prone position
* T6: 30min after T5
* T7: 60min after T6
* T8: 120min after T7
* T9: 180min after T8
* T10: at the end of the surgery and the patient in supine position At the time of each tonometer reading the following data set is collected: MAP, heart rate, EtCO2, SpO2, CO, SV, SVV, urine output, Psi, IOP. Moreover OPP will be calculated as MAP minus IOP.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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DEX group
Dexmedetomidine given at a bolus dose of 1,0 μg/kg 10min before induction of anesthesia and then after as a continuous infusion 0,4-0,8 μg/kg/h until the end of the surgery.
Dexmedetomidine
Administration
Placebo group
Normal saline given as a bolus dose 10min before induction of anesthesia and then after as a continuous infusion until the end of the surgery.
Normal Saline
Administration
Interventions
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Dexmedetomidine
Administration
Normal Saline
Administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with previous eye surgery
* Preexisting eye disease (e.g glaucoma)
* Allergy to the study drug or any drug which is in the trial
* Preoperative unstable hemodynamics
18 Years
90 Years
ALL
No
Sponsors
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Attikon Hospital
OTHER
Responsible Party
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Paraskevi Matsota
Prof of Anaesthesiology
Principal Investigators
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Paraskevi Matsota, Prof
Role: STUDY_CHAIR
2nd Department of Anesthesiology, Attikon University Hospital
Locations
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2nd Department of Anesthesiology, Attikon University Hospital
Athens, Attica, Greece
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DEXIOPSPS
Identifier Type: -
Identifier Source: org_study_id
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