Comparing General Anesthesia With Single Injection Peribulbar Block With Articaine 4% vs Lidocaine 2% vs Mepivacaine 3 % for Prevention of Oculocardiac Reflex in Children Undergoing Strabismus Surgery : A Randomized Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- The incidence of Intraoperative oculocardiac reflex.
研究概览
简要总结
To compare the effect of the used local anesthetics in this study on decreasing the incidence of oculocardiac reflex . To evaluate the efficacy of Articaine 4 % , mepivacaine 3% and lidocaine 2% regarding post- operative analgesia.
详细描述
Population of study: Children undergoing strabismus surgery aged from 7 to 14 years .
- 55 participants grouped randomly into 3 groups :
- Group A :will receive General Anesthesia combined with Peribulbar Block with 5ml of Articaine 4% with 1/100000 adrenaline and 10 International Units (IU) of Hyaluronidase .
- Group L :will receive General Anesthesia combined with Peribulbar Block with 5ml of Lidocaine 2% and 10 IU of Hyaluronidase .
- Group M : will receive General Anesthesia combined with Peribulbar Block with 5 ml of mepivacaine 3% and 10 IU of Hyaluronidase
- Methodology in details:
After obtaining informed written consent from the parents of children after explaining the procedure to them, random allocation of patients into three groups will be done.
In all groups: upon arrival to the operating room, preoperative sedatives in the form of midazolam 0.05 mg/kg by Intravenous route will be used ,standard monitor including; electrocardiogram (ECG), non-invasive blood pressure and pulse oximeter were attached to the patients. The induction of anesthesia will be by intravenous route .
Insertion of 24-22 Gauge Intravenous (IV) catheter and appropriate size laryngeal mask airway (LMA) will be inserted . Anesthesia will be maintained using 100% oxygen and sevoflurane with spontaneous respiration and capnogram will be attached to obtain continuous measurement of end-tidal carbon dioxide (ETCO2).
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, Care Provider)
入排标准
- 年龄范围
- 7 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ASA I , II.
- •Age from 7 to 14 years old.
- •Patients undergoing Strabismus Surgery
排除标准
- •Patients with ASA III ,IV.
- •Patients with Endophthalmitis , orbital fractures.
- •Any Congenital or Cardiac anomalies.
- •Patients with history of allergy to local anesthetics.
- •Revision Surgeries.
- •Refusal of the Surgeon. Refusal of the patients' parents
研究组 & 干预措施
For group A
Group A will be inducted as before in addition of giving a peribulbar block up to 5 ml ( according to the volume of the eye ) of Articaine 4 % with adrenaline 1/100000 mixed with 10IU of Hyaluronidase by a single injection technique: a 26/27 gauge needle will be inserted as far laterally as possible in the inferotemporal quadrant. Once the needle is under the globe, it will be directed along the orbital floor, passing the globe equator to a depth controlled by observing the needle/hub junction reaching the plane of the iris. After negative aspiration for blood, with the globe in primary gaze, and start injection and the injected volume will be guided by digital intraocular pressure.
干预措施: Articaine and Epinephrine Only Product (Drug)
Group L
General Anesthesia will be inducted as before in addition of giving a peribulbar block up to 5 ml ( according to the volume of the eye ) of Lidocaine 2%mixed with 10IU of Hyaluronidase by a single injection technique.
干预措施: levobupivacaine (Drug)
Group M
General Anesthesia will be inducted as before in addition of giving a peribulbar block up to 5 ml (according to the volume of the eye) of Mepivacaine 3% mixed with 10IU of Hyaluronidase by a single injection technique.
干预措施: mepivacaine (Drug)
结局指标
主要结局
The incidence of Intraoperative oculocardiac reflex.
时间窗: intraoperative
次要结局
未报告次要终点