Actively Recruiting
Effects of Systemic Administration of Dexmedetomidine on Intraocular Pressure During Scheduled Spine Surgeries in a Prone Position Prospective, Randomized, Double-blinded Study
Led by Attikon Hospital · Updated on 2025-09-30
60
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of giving dexmedetomidine during spine surgeries performed with patients lying face down under general anesthesia. This trial aims to see how this drug affects the pressure inside the eyes, called intraocular pressure (IOP), which can be important for patient safety during surgery. The study is a prospective, randomized, placebo-controlled, double-blinded clinical trial involving adult patients with ASA physical status I, II, or III. Participants will be randomly assigned to one of two groups. One group will receive dexmedetomidine as a bolus dose of 1.0 microgram per kilogram 10 minutes before anesthesia induction, followed by a continuous infusion of 0.4 to 0.8 microgram per kilogram per hour until the surgery ends. The other group will receive an identical volume of normal saline as placebo in the same schedule. All patients will receive the same type of anesthesia using propofol and postoperative pain management with paracetamol and wound infiltration with ropivacaine. During the surgery, various vital signs and parameters will be monitored, including heart rate, blood pressure, oxygen levels, cardiac output, and urine output. Eye pressure will be measured in both eyes at multiple time points before, during, and after surgery using a specialized tonometer by an ophthalmologist who does not know the treatment group. The main outcome measured is the intraocular pressure up to 15 minutes after surgery ends. The study will also calculate ocular perfusion pressure as part of the monitoring. Participation duration depends on the surgery and follow-up measurements shortly after.
CONDITIONS
Brief Title
Effects of Dexmedetomidine on Intraocular Pressure During Scheduled Spine Surgeries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients undergoing scheduled spine surgery performed in prone position under general anaesthesia
You will not qualify if you...
- Patients who refuse to be a part of the study
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of scheduled spine surgery
Participants receive dexmedetomidine or saline starting 10 minutes before anesthesia induction and continuing until the end of the spine surgery performed in prone position under general anesthesia.
1 surgery day visit (in-person)
Duration - Up to 15 minutes after the end of operation
Participants undergo intraocular pressure measurements and monitoring immediately after surgery up to 15 minutes post-operation.
1 post-operative visit (in-person)
Trial Site Locations
Total: 1 location
1
2nd Department of Anesthesiology, Attikon University Hospital
Athens, Attica, Greece, 12462
Actively Recruiting
Research Team
P
Paraskevi Matsota, Prof
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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