Dexmedetomidine as an Additive to Local Anaesthesia to Decrease Intraocular Pressure in Glaucoma Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- IOP before the block, after the message and before the surgical incision, after the end of the surgery
研究概览
简要总结
Nowadays, a number of cases with increased intraocular pressure and glaucoma have been shown a huge increase . This is because of the increase the geriatric population in the community and advanced medical care. Surgical correction, as a treatment, solves this problem greatly especially with the modern surgical techniques .
Peribulbar block reduced the admission discharge time and reduced the burden on both the patients and the medical team. On the other hand, it carries the risk of increased intraocular pressure (IOP). Which, subsequently, limit its usage in glaucoma surgery.
Dexmedetomidine, as an alpha 2 agonist, has a well-established role in decreasing intraocular pressure (IOP). This effect has been shown at a histological level and clinical level
详细描述
Nowadays, number of cases with increased intraocular pressure and glaucoma has been shown a huge increase . This is because of the increase the geriatric population in the community and advanced medical care. Surgical correction, as a treatment, solves this problem greatly especially with the modern surgical techniques .
Peribulbar block reduced the admission discharge time and reduced the burden on both the patients and the medical team. On the other hand, it carries the risk of increased intraocular pressure (IOP). Which, subsequently, limit its usage in glaucoma surgery .
Dexmedetomidine, as an alpha 2 agonist, has a well established role in decreasing intraocular pressure (IOP). This effect has been shown at a histological level and clinical level . It has been tested in many studies before as an additive to local anaesthetic to augment the effect of the block and to achieve an accepted level of patient sedation (**). Many routes have been tested such as intravenous infusion, intramuscular injection and topically with the local anaesthesia . There is a debate about the best route and the optimum dose that can achieve the desired clinical effect with the least side effects.
There is no study, till now, has examined the effect of Dexmedetomidine in a diseased eye with pathology that leads to increased IOP. This study states the hypothesis that Dexmedetomidine locally as an additive to local anaesthesia in different doses, not only will increase the duration of the block or achieve some level of sedation, but also can reduce the IOP in this diseased eye to a level that will help the surgical conditions and improve the surgical outcome.
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
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patients who were ASA I-III, age more than 25 and less than 80 with diagnosed increased intraocular pressure and were legible for surgical correction
排除标准
- •Patients with known allergy to the medications to be given, ASA more than III, age less than 25 or more than 80, dementia, deafness, psychological disease, difficult to communicate, cannot lay flat, INR more than 1.7 or with significant coagulopathy
研究组 & 干预措施
D50 Dexmedetomidine 50 micrograms group
peribulbar block was given using 10 ml of a mixture of local anesthetics. The mixture was composed of 5 ml of 0.5% bupivacaine +4.5 ml of 2% lidocaine +0.5ml of 50 micrograms of Dexmedetomidine with 150 IU hyaluronidase.
干预措施: Dexmedetomidine to reduce the IOP (Drug)
D25 Dexmedetomidine 25 micrograms group
peribulbar block was given using 10 ml of a mixture of local anesthetics. The mixture was composed of 5 ml of 0.5% bupivacaine + 4.5 ml of 2% lidocaine +0.5ml of 25 micrograms of Dexmedetomidine with 150 IU hyaluronidase.
干预措施: Dexmedetomidine to reduce the IOP (Drug)
control
peribulbar block was given using 10 ml of a mixture of local anesthetics without Dexmedetomidine. The mixture was composed of 5 ml of 0.5% bupivacaine +4.5 ml of 2% lidocaine +0.5ml with 150 IU hyaluronidase.
干预措施: Dexmedetomidine to reduce the IOP (Drug)
结局指标
主要结局
IOP before the block, after the message and before the surgical incision, after the end of the surgery
时间窗: one hour
IOP before the block, after the message and before the surgical incision, after the end of the surgery
次要结局
- Onset of the block(2 min)
研究者
Hassan Mohamed Ali
Hassan Mohamed Ali
Cairo University