Dexmedetomidine as an Additive to Topical Versus Peribulbar Anesthesia for Cataract Surgery
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Inadvertent eye movement
研究概览
简要总结
The aim of this study is to compare efficacy of dexmedetomidine as an additive to topical versus peribulbar anesthesia for cataract surgery
详细描述
Ocular surgery may be performed under topical, regional, or general anesthesia. The first recorded use of regional anesthesia for surgery was the instillation of cocaine into the conjunctival sac in 1884 by an Austrian ophthalmologist.
Davis and Mandel in 1986 described the peribulbar block, peribulbar block has delayed onset and need a higher volume of local anesthetic (LA) than a retrobulbar block. But the peribulbar block is away from intra-conal space and so produce fewer complication.
Dexmedetomidine is used as adjuvant to LA drugs in peripheral nerve block, brachial plexus block and intrathecal anesthesia with satisfactory results. A more recent study using dexmedetomidine (50 μg) with the peribulbar block before cataract surgery demonstrated an IOP decrease similar to IV dexmedetomidine administration and greater than a peribulbar block without dexmedetomidine.
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
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status classification I or II who scheduled for eye surgery
排除标准
- •Patients who are younger than 18 years
- •The usual contraindications for regional anesthesia such as patients refusing LA
- •Clotting abnormalities
- •Impaired mental status
- •Allergy to any of the study medications
- •patients had the severe cardiac disease
- •chronic obstructive lung disease and a history of sleep apnea
- •contraindications to the use of dexmedetomidine
- •history or significant cardiovascular disease risk factors
- •significant coronary artery disease or any known genetic predisposition
- •history of any kind of drug allergy
- •drug abuse
- •psychological or other emotional problems
- •special diet or lifestyle
- •clinically significant abnormal findings in physical examination
- •electrocardiographic (ECG) or laboratory screening
- •known systemic disease requiring the use of anticoagulants.
研究组 & 干预措施
Topical dexmedetomidine group
Patients will receive mixture of one milliliter of dexmedetomidine-HCl and local anesthetic
干预措施: Topical dexmedetomidine (Drug)
Reginal dexmedetomidine group
Patients will receive mixture of bupivacaine 0.5% (4.5 ml) + lidocaine 2% (4.5 ml) + dexmedetomidine 50 μg (1 ml) in peribulbar block
干预措施: Reginal dexmedetomidine (Drug)
结局指标
主要结局
Inadvertent eye movement
时间窗: 2 hours postoperatively
Asses intra-ocular pressure (IOP) before injection of baseline and after a complete akinesia of the globe before surgical incision.
次要结局
- Anesthesia-related complications(2 hours postoperatively)
- Sedation level(2 hours postoperatively)
- pain during and after the surgery(2 hours postoperatively)
- Need for additional anesthesia during surgery and surgeon(During surgery)
- Intraoperative difficulties(2 hours postoperatively)
研究者
Mohamed Fouad Algyar
Lecturer of Anaesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelsheikh University
Kafrelsheikh University