Efficacy and Safety of Low Dose Atracurium Added to Lidocaine, Bupivacaine and Hyaluronidase Mixture in Percaruncular Peribulbar Anesthesia for High Myopes Undergoing Phacoemulsification: A Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- assessing the quality of akinesia (onset and duration) of low dose atracurium added to lidocaine, bupivacaine and hyaluronidase mixture in Percaruncular peribulbar block
研究概览
简要总结
There are several local anesthetic techniques available for cataract surgery and the choice depends on patient, surgical and operator factors. The eyes of patients with axial myopia (the eye globe is abnormally elongated) have thin wall (sclera), limited space for needle insertion for local anesthetic injection between the globe and the orbit and out-pouching of the back of the eye (staphyloma). These factors increased the risk of perforation following conventional needle techniques of eye block The current study technique is per-caruncular injection (the needle insertion site is between the nasal side of the globe and bony orbit) which may provide a safer alternative to the conventional needle techniques for myopic patients. The space of injection is devoid of blood vessels moreover, myopic staphylomata are infrequently located on the nasal side of the globe.
Local injection of muscle relaxant added to local anesthetic solution may provide earlier onset of eye muscle paralysis thus earlier onset of favorable surgical condition than local anesthetic solution alone.
The current study will demonstrate the effect of adding low dose atracurium (a muscle relaxant) to local anesthetic mixture in providing early onset of eye muscle paralysis and favorable surgical condition in per-caruncular technique of eye block in high myopes undergoing cataract surgery.
详细描述
In the current study, it is hypothesized that adding low dose atracurium to lidocaine, bupivacaine and hyaluronidase mixture would provide an early onset of akinesia and favorable surgical condition in per-caruncular peribulbar anesthesia for high myopes undergoing phacoemulsification Initially, informed consents from the eligible patients will be obtained. Preoperatively, the axial length of the enrolled patients will be measured by ultrasound biometry and the presence of staphyloma was identified by B-scan.
In the preparation room, the intravenous (IV) cannula will be placed. Anxious patients will be given midazolam intravenously (titrated to response according to patient's age and associated medical condition).
In the operating room, standard monitoring of pulse oximetry, electrocardiography (ECG) and noninvasive arterial blood pressure will be commenced. The O2 will be administered at 2 ml/minutes by the nasal O2 cannula. Drugs and equipment for resuscitation will be checked before initiation of the procedure.
Local anesthetic eye drops (benoxinate 0.4%) will be instilled in the eye to be operated upon three times separated by one minute interval.
The patient will lie in a supine position and will be asked to look directly ahead focusing on a fixed point on the ceiling, so that the eyes are in the neutral position. A per-caruncular will be given using a 25 Gauge (G), 25 mm needle. The needle insertion point will be just medial to the caruncle with the needle passing directly perpendicular to the face and parallel to the medial orbital wall to 15-20 mm depth. , After negative aspiration the already chosen local anesthetic mixture will be injected slowly. During injection, the globe will be palpated with one finger and tension in the lids will be tested frequently, if the lids become tense or if the tension is felt to rise in the globe, the injection will be stopped. After injection, external compression with Honan balloon inflated to 20-30 mm Hg will be applied for 10 minutes and will be removed every 2 minutes to test akinesia and anesthesia.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I-III
- •high myopia (axial length 26mm or more)
排除标准
- •Pregnant patients.
- •ASA physical status >III.
- •Axial length less than 26 mm.
- •Contraindication of regional anesthesia:
- •Absolute contraindications: Patient refusal to participate in the study, Local anesthetic allergy and Infection/marked orbital inflammation or, Relative contraindications: unable to lie flat for a sufficient length of time, Confusion or psychiatric illness, communication difficulties, bleeding diathesis or taking anticoagulants, Previous scleral buckling or space-occupying lesions within the orbit
研究组 & 干预措施
Group C
2.5 ml of lidocaine 2% 2.5 ml of bupivacaine 0.5% hyaluronidase powder 15 IU/ml
1 ml normal saline to make a total volume of 6 ml from which the patient received 5-6 ml through percaruncular peribulbar injection.
干预措施: Lidocaine 2% (Drug)
Group C
2.5 ml of lidocaine 2% 2.5 ml of bupivacaine 0.5% hyaluronidase powder 15 IU/ml
1 ml normal saline to make a total volume of 6 ml from which the patient received 5-6 ml through percaruncular peribulbar injection.
干预措施: Bupivacaine 0.5% (Drug)
Group C
2.5 ml of lidocaine 2% 2.5 ml of bupivacaine 0.5% hyaluronidase powder 15 IU/ml
1 ml normal saline to make a total volume of 6 ml from which the patient received 5-6 ml through percaruncular peribulbar injection.
干预措施: hyaluronidase powder (Drug)
Group C
2.5 ml of lidocaine 2% 2.5 ml of bupivacaine 0.5% hyaluronidase powder 15 IU/ml
1 ml normal saline to make a total volume of 6 ml from which the patient received 5-6 ml through percaruncular peribulbar injection.
干预措施: per-caruncular peribulbar injection (Procedure)
Group A
5 mg atracurium 2.5 ml of lidocaine 2% 2.5 ml of bupivacaine 0.5% hyaluronidase 15 IU/ml
1 ml normal saline to make a total volume of 6 ml from which the patient received 5-6 ml through percaruncular peribulbar injection.
干预措施: Atracurium (Drug)
Group A
5 mg atracurium 2.5 ml of lidocaine 2% 2.5 ml of bupivacaine 0.5% hyaluronidase 15 IU/ml
1 ml normal saline to make a total volume of 6 ml from which the patient received 5-6 ml through percaruncular peribulbar injection.
干预措施: Lidocaine 2% (Drug)
Group A
5 mg atracurium 2.5 ml of lidocaine 2% 2.5 ml of bupivacaine 0.5% hyaluronidase 15 IU/ml
1 ml normal saline to make a total volume of 6 ml from which the patient received 5-6 ml through percaruncular peribulbar injection.
干预措施: Bupivacaine 0.5% (Drug)
Group A
5 mg atracurium 2.5 ml of lidocaine 2% 2.5 ml of bupivacaine 0.5% hyaluronidase 15 IU/ml
1 ml normal saline to make a total volume of 6 ml from which the patient received 5-6 ml through percaruncular peribulbar injection.
干预措施: hyaluronidase powder (Drug)
Group A
5 mg atracurium 2.5 ml of lidocaine 2% 2.5 ml of bupivacaine 0.5% hyaluronidase 15 IU/ml
1 ml normal saline to make a total volume of 6 ml from which the patient received 5-6 ml through percaruncular peribulbar injection.
干预措施: per-caruncular peribulbar injection (Procedure)
结局指标
主要结局
assessing the quality of akinesia (onset and duration) of low dose atracurium added to lidocaine, bupivacaine and hyaluronidase mixture in Percaruncular peribulbar block
时间窗: from onset of ocular akinesia up to 24 hours postoperatively
This will be achieve by assessing ocular movement score (OMS) every 2 minutes by asking the patient to move his/her eye in four directions; up, down, medially and laterally and the movement in each direction is given a score from 0 to 2 as follows: movement more than 2 mm will be given a score of 2, 1-2 mm movement will be given a score of 1 and no movement will be given a score of 0. A total Score of 2 or less will be considered adequate akinesia for surgery. Also, eyelid movement score will be assessed by asking the patient to open his/her eye widely followed by squeezing them maximally. A full movement will be given a score of 2, the flickering will be given a score of 1 and no movement will be given a score of 0.
次要结局
未报告次要终点
研究者
Maha Mostafa Ahmad, MD
Assistant Lecturer - Anesthesia, pain management and surgical ICU department
Kasr El Aini Hospital