Efficacy of Midazolam Addition to Local Anesthetic in Peribulbar Block. Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Quality of the sensory and motor block
研究概览
简要总结
Regional eye blocks are usually preferred for ophthalmic procedures. Peribulbar block (PBB) is a safe alternative for patients undergoing cataract surgery. Many studies tried to solve this issue by means of prolonging the duration of action of the local anesthetics used. Several drugs were tried as adjuncts to local anesthetics, and their effects have been studied. Midazolam added to the list of adjuvant used in the subarachnoid or epidural block can produce analgesia, probably mediated by the benzodiazepine-Gamma Amino-Butyric Acid(GABA) receptor complex.
The investigators hypothesized that the addition of midazolam to lidocaine will improve the quality of the peribulbar block; fasten the onset and prolonging its anesthetic and analgesic duration.
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •90 adult patients with ASA physical status I to III
- •Aged 40-70 years
- •Scheduled for elective extracapsular or phacoemulsification cataract surgery with peribulbar block
- •No history of allergy to local anesthetics
- •Axial length less than 28 mm.
排除标准
- •Patient's refusal to share in the study
- •communication barrier (e.g. impaired hearing, disturbed conscious level, impaired mental status)
- •uncontrolled tremors
- •morbidly obese patients
- •allergy to lidocaine
- •coagulation abnormalities
- •recent surgical procedure on the same eye.
研究组 & 干预措施
Group C(control)
Peribulbar block without midazolam (peribulbar block using a mixture of lidocaine 2%, hyaluronidase 15 IU / ml)
干预措施: Peribulbar block (control) (Procedure)
Group M1
Peribulbar block with midazolam 50 µg (peribulbar block using a mixture of lidocaine 2%, hyaluronidase 15 IU / ml. plus midazolam 50 µg/ml)
干预措施: Peribulbar block(M1) (Procedure)
Group M2
Peribulbar block with midazolam 100 µg(peribulbar block using a mixture of lidocaine 2%, hyaluronidase 15 IU / ml. plus midazolam 100 µg/ml
干预措施: Peribulbar block(M2) (Procedure)
结局指标
主要结局
Quality of the sensory and motor block
时间窗: 6 hours
The quality of the sensory and motor block was assessed using the Ocular Anesthesia Scoring System (OASS). Patients were categorized into three groups according to the quality of the block and level of anesthesia achieved: poor (0-3), average (4-9) and good block (10-14)
次要结局
- local or systemic complications(6 hours)
- Onset and duration of block(6 hours)
- Analgesia(4 hours postoperative)