Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04628663 |
| Other study ID # |
DEXIOPSPS |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 20, 2021 |
| Est. completion date |
January 2025 |
Study information
| Verified date |
January 2024 |
| Source |
Attikon Hospital |
| Contact |
Paraskevi Matsota, Prof |
| Phone |
6945544563 |
| Email |
matsota[@]yahoo.gr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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:
- 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.
