Comparison Between 2% Lidocaine Gel and 5% Tetracaine Eye Drop as Topical Anesthesia in Phacoemulsification
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Visual analog scale
研究概览
简要总结
This study aimed to compare the efficacy between 2% lidocaine gel vs 0.5% tetracaine eye drop as topical anesthesia in phacoemulsification
详细描述
Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study and randomized into two groups (Lidocaine gel and tetracaine eye drop group). Lidocaine group received 2% lidocaine gel in 1 ml syringe, applied to the eye. Tetracaine group received 0.5% tetracaine eye drop. Topical anesthesia was given 5 minutes before phacoemulsification. Five minutes after phacoemulsification finished, visual analog score (VAS) and subjects and surgeon's satisfaction were assessed. Every additional topical anesthesia needed was recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged more than 40 years old who were planned to undergo elective phacoemulsification with intraocular lens implantation at operating room. The surgery was operated by an experienced ophthalmologist. Subjects had been explained about the study, and agreed to enroll and have signed the informed consent form.
排除标准
- •Subjects with history of allergy to topical anesthesia (2% lidocaine gel and 0.5% tetracaine eye drop), subjects who used another method of intraoperative anesthesia other than topical anesthesia, subjects with history of phacoemulsification before, subjects with difficulty in communication, dementia, and anxiety.
- •Dropout Criteria:
- •Phacoemulsifications duration more than 30 minutes, and subjects who resigned from the study before the study ended
研究组 & 干预措施
lidocaine gel
Lidocaine gel group: received 2% lidocaine gel in 1 ml syringe, applied to the eye 5 minutes before phacoemulsification
干预措施: lidocaine gel (Drug)
tetracaine eye drop
Tetracaine eye drop group: received 0.5% tetracaine eye drop 5 minutes before phacoemulsification
干预措施: tetracaine eye drop (Drug)
结局指标
主要结局
Visual analog scale
时间窗: Day 1
assessing subject's pain with visual analog scale
次要结局
- Additional topical anesthesia requirement(Day 1)
- Subjects and surgeon's satisfactory(Day 1)
研究者
Susilo Chandra
Anesthesiologist Consultant
Indonesia University