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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEX group | Active Comparator | 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. |
|
| Placebo group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Administration |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure (IOP) | The measurement of IOP will be conducted in both eyes with Icare PRO tonometer by an ophthalmologist at predefined time points | Up to 15 minutes after the end of operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paraskevi Matsota, Prof | Contact | 6945544563 | matsota@yahoo.gr |
| Name | Affiliation | Role |
|---|---|---|
| Paraskevi Matsota, Prof | 2nd Department of Anesthesiology, Attikon University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2nd Department of Anesthesiology, Attikon University Hospital | Recruiting | Athens | Attica | 12462 | Greece |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Prospective, Randomized, Placebo -controlled, Double-Blinded clinical trial
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Not aware of the study group
| Normal Saline | Other | Administration |
|
|
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |