An interventional study of Dexmedetomidine and Normal Saline in Intraocular Pressure, sponsored by Attikon Hospital. Recruiting at 1 site in Greece. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-09-30.
Sponsored by Attikon Hospital · Not applicable, Interventional, and Prevention
The aim of this study is to examine the effects of intraoperative systemic use of dexmedetomidine on the intraocular pressure (IOP) in patients undergoing spine surgeries in a prone position under general anesthesia.
The study is a Prospective, Randomized, Placebo -controlled, Double-Blinded clinical trial Adult patients with an ASA physical status of class I, II or III who are scheduled for an elective spine surgery in prone position under general anesthesia will be included in the study.
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:
Attikon Hospital is the lead sponsor of 86 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
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.
Drug: Dexmedetomidine
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.
Other: Normal Saline
Administration
Also known as: Dexmed
Administration
Also known as: Saline
Intraocular pressure (IOP)
The measurement of IOP will be conducted in both eyes with Icare PRO tonometer by an ophthalmologist at predefined time points
Time frame: Up to 15 minutes after the end of operation
Plan to share: No
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Studies of the drug tested here: Dexmedetomidine
Attikon Hospital