Effects of Clonidine Added to Lidocaine in Sub-Tenon's and Peribulbar Anesthesia: Assessments of Intraocular Pressure (IOP), Ocular Perfusion Pressure (OPP) and Ocular Pulse Amplitude (OPA)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 主要终点
- Intraocular Pressure (IOP)
研究概览
简要总结
Regional anesthesia in orbit can reduce ocular blood flow, increase in intraocular pressure (IOP) or the pharmacological action of local anesthetics. This study was conduced to evaluate the effects of clonidine added to lidocaine in IOP, ocular perfusion pressure (PPO) and ocular pulse amplitude (OPA) in patients undergoing cataract surgery under sub-Tenon's and peribulbar anesthesia.
详细描述
In this prospective randomized and double blind clinical study, involving 80 patients with ages from 30 to 86 years old, ASA I and II, both genders. The patients were randomly divided into 4 groups of 20 patients, and then were administered in control sub-Tenon's group 5 mL of 2% lidocaine with 1 mL of 0.9% sodium chloride solution; in sub-Tenon's group clonidine, 5 mL of 2% lidocaine associated with 1 µg/kg of clonidine diluted in 1 mL 0.9% sodium chloride solution. In the peribulbar anesthesia, the control group with 6 mL of 2% lidocaine and 1 mL of 0.9% sodium chloride solution, and peribulbar group clonidine, 6 mL of 2% lidocaine associated with 1 µg/kg of clonidine diluted in 1 mL 0.9% sodium chloride solution. Were evaluated the systemic hemodynamic variables; IOP and OPA measurements according the dynamic contour tonometer (DCT) and calculation of OPP, prior to the blockade (M0), and one (M1), five (5) and ten minutes (M10) after the injection of the anesthetic solutions. Complications related to the sub-Tenon's and peribulbar anesthesia were recorded.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 86 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults between 30 and 86 years old
- •Both genders
- •Physical status ASA (American Society of Anesthesiologists) I and II
- •Cooperative patients undergoing cataract surgery by phacoemulsification
排除标准
- •Patients with communication difficulties
- •Allergic to any medication protocol
- •Chronic therapy with clonidine
- •In use of antihypertensive medication
- •Previous surgery in the same eye
- •Abnormalities in coagulation
研究组 & 干预措施
Sub-Tenon's group clonidine
2% Lidocaine without epinephrine plus clonidine 1 µg/kg
干预措施: Clonidine (Drug)
Peribulbar group clonidine
2% Lidocaine without epinephrine plus clonidine 1 µg/kg
干预措施: Clonidine (Drug)
结局指标
主要结局
Intraocular Pressure (IOP)
时间窗: Within 10 minutes before the surgery procedure
次要结局
未报告次要终点
研究者
Renato Santiago Gomez
Head of surgery department of the medical school of the Federal University of Minas Gerais
Federal University of Minas Gerais
