Prospective Randomised Double-blind Study to Compare Ropivacaine 10mg/mL Alone Versus Ropivacaine 10mg/mL Associated With Clonidine 1µg/kg for Peribulbar Anesthesia in Posterior Eye Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Dose of ropivacaine injected 10 mg/ml: necessary to obtain complete ocular akinesia
研究概览
简要总结
This is a study conducted in 60 patients, randomly assigned to one of two groups of 30: the first will receive ropivacaine alone and the second will receive the association ropivacaine/clonidine.
The aim of the study is to prove that the association of Clonidine with Ropivacaine is more effective than ropivacaine alone for locoregional anaesthesia of the eye for retinal surgery.
The principal interest of this association of drugs is that it procures faster and longer anaesthesia of the eye with less ropivacaine (therefore fewer injections). This provides greater comfort to the patient during and after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who have given written informed consent
- •any adult patient about to undergo their first operation involving the posterior segment of the eye under peribulbar anaesthesia
排除标准
- •persons without National Health Insurance
- •pregnant or breast-feeding women, patients < 18, patients who cannot give their consent, patient's refusal of Loco-Regional Anesthesia, patients who cannot remain in dorsal decubitus dorsal for at least 1h
- •contra-indication for Loco-Regional Anesthesia
- •hypersensitivity to the study drugs (ropivacaine, clonidine), to the corresponding excipients or hypersensitivity to local anaesthetics other than amide-type ropivacaine.
- •disorders of periorbital or oculomotor sensitivity, patients with glaucoma, patients with chronic pain and on morphines
- •uncontrolled arterial hypertension, clonidine per os at home, arterial hypotension before the intervention (SAP < 90 mmHg)
- •Surgery for diabetic retinopathy, patients with unbalanced diabetes, eye with prior posterior segment surgery
- •Contra-indications mentioned on the summary of product characteristics for clonidine (known hypersensitivity to the active ingredients or one of its excipients, Heart rate below 60bpm, severe Bradycardia due to sinoatrial node disease or second or third degree atrioventricular block, Depression, Sultopride).
研究组 & 干预措施
Ropivacaine alone group
干预措施: 5 ml Ropivacaine 10% + physiological saline (Drug)
Ropivacaine/Clonidine group
干预措施: 5 ml Ropivacaine 10% + Clonidine 1 µg/kg (Drug)
结局指标
主要结局
Dose of ropivacaine injected 10 mg/ml: necessary to obtain complete ocular akinesia
时间窗: up to 1 hour
次要结局
- Time to achieve akinesia(up to 1 hour)