Comparative Study Between Dexmedetomidine & Neostigmine as an Adjuvant to Local Anesthetic Mixture in Peribulbar Block in Vitreoretinal Surgeries
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Onset & Duration of sensory and motor block
研究概览
简要总结
The majority of patients undergoing ophthalmic surgeries are elderly, with multiple chronic diseases, with increased risk of morbidity and mortality under general anesthesia.
Peribulbar anesthesia is widely practiced now as a first-choice local block for ophthalmic surgeries.
Dexmedetomidine is a highly selective alpha-2 adrenoceptor. It increases central and peripheral nerve blockade and when added to local anesthetic as an adjuvant, it will provide better anesthetic quality as well as prolongation of postoperative analgesia .
Neostigmine is a parasympathomimetic drug that increase the level of acetylecholine at peripheral muscarinic receptors present in the peripheral nerve endings .
Many researches examined the analgesic effects of peripherally administered neostigmine as in intravenous regional anesthesia reporting that addition of neostigmine to the local anesthetic solution accelerated the onset of anesthesia
& prolong duration .
详细描述
81 participants divided into three groups 27 patient in each group with inclusion criteria :
- Patients aged from 21 to 60 years.
- Patients ASA I to II undergoing Vitreoretinal Surgeries.
- Patient with axial globe length below 26 mm.
- Patients consented with Local anesthesia.
The three groups:
group I : will receive Peribulbar anesthesia block via 25G needle is inserted transcutaneously through the inferotemporal approach at the junction between the medial two third and the lateral third of the lower orbital margin in such a way the bevel is facing the globe and the tip towards the floor of the orbit until the needle passes through the orbital septum it is directed then posteriorly tangential to the floor of the orbit for 25mm length at which the 8 ml local anesthetic mixture is injected ( 4 ml of bupivacaine + 3 ml of mixture of Lidocaine & Hyaluronidase +1ml of Dexmedetomidine equivalent to 25 mcg).
Ocular compression is applied for 5 minutes by Honan intraocular pressure IOP reducer adjusted at 20mmHg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged from 21 to 60 years.
- •Patients ASA I to II .
- •Patient with axial globe length below 26 mm.
- •Patients consented with Local anesthesia.
排除标准
- •Patient refusal.
- •Patients below or above the age.
- •Patients with bleeding disorders.
- •Patient with axial globe length more than 26 mm.
- •history of relevant drug allergy to any of the used drugs
研究组 & 干预措施
Dexmeditomedine group
Patients in this group will receive Dexmeditomedine in Local anesthesia mixture.
干预措施: Dexmedetomidine (Drug)
Neostigmine group
Patients in this group will receive Neostigmine in Local anesthesia mixture.
干预措施: Neostigmine (Drug)
Control group
Patients in this group will receive saline (placebo) in Local anesthesia mixture.
干预措施: Saline (Drug)
结局指标
主要结局
Onset & Duration of sensory and motor block
时间窗: 12 hours
By minutes , Refers to the time from injection till patient will feel nothing in his eyes , then the time when he regain feeling again
次要结局
- Systolic & Diastolic Arterial Blood Pressure(12 hours)
- Heart rate(12 hours)
- Patient & Surgeon satisfaction(12 hours)
研究者
Hussein Hamdy
Assistant lecturer
Ain Shams University