Effects of Systemic Administration of Dexmedetomidine on Intraocular Pressure During Scheduled Spine Surgeries in a Prone Position. Prospective, Randomized, Double-blinded Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Intraocular pressure (IOP)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Not aware of the study group
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients undergoing scheduled spine surgery performed in prone position under general anaesthesia
排除标准
- •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
研究组 & 干预措施
DEX group
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.
干预措施: Dexmedetomidine (Drug)
Placebo group
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.
干预措施: Normal Saline (Other)
结局指标
主要结局
Intraocular pressure (IOP)
时间窗: Up to 15 minutes after the end of operation
The measurement of IOP will be conducted in both eyes with Icare PRO tonometer by an ophthalmologist at predefined time points
次要结局
未报告次要终点
研究者
Paraskevi Matsota
Prof of Anaesthesiology
Attikon Hospital