Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
ID04628663

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

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients undergoing scheduled spine surgery performed in prone position under general anaesthesia
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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)

Post-treatment Follow-up

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

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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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