Comparative Study Between Different Additives to Local Anesthetics: Dexamethasone Versus Magnesium Sulfate in Medial Episcleral Technique in Keratopalsty Surgeries
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Primary outcome: Time to onset of accepted akinesia score and Need of supplemental injection in each group.
研究概览
简要总结
The aim of this work is to compare between the effects of addition of Dexamethasone versus magnesium sulfate to local anesthetic mixture in medial episcleral technique in keratoplasty operations
详细描述
The aim of this work is to compare between the effects of addition of Dexamethasone versus magnesium sulfate to local anesthetic mixture in medial episcleral technique in keratoplasty operations Pilot study will be done on 60 patients (20/group).
-The patients will be randomized into 3 equal groups by computer generated randomization in which all patients will receive medial canthus episcleral technique with local anesthetic mixture with different additives.
preoperative investigation as CBC ,,LFT KFT, . coagulation profile , ECG and echo for the risky patients ASA III. preoperative medication .antiemetic dexamesthasone 0.06mg\kg sedative midazolame 0.15mg\kg given before the the block within 20-30 minutes . patient is connected to full ASA monitor ECG ,SPO2 probe NIBP and connected to nasal cannula 3l\m of oxygen The procedure is done in the operating rooms (OR) under complete aseptic technique.
Preparations that will be used for each patient are:
- Sterile towels, sponges, 4-inch gauze packs and povidone iodine 5% for sterilization, sterile gloves, 25Gx5/8 inch needle and 25Gx1inch needle
- The study drugs (commercially available forms) that will be used are:
- A 20 ml vial of 0.5% (Bupivacaine hydrochloride) equivalent to 5mg/ml
- A 50ml vial of 2% (Lidocaine hydrochloride) equivalent to 20mg/ml with 1500IU Hyaluronidase dissolved in the vial (30IU/ml).
- Each group will receive a total volume of 10ml formed of:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •o Physical Status: ASA (American society of Anesthesiologists) I - II patients.
- •Both sexes.
- •Axial length of the globe is 22-30mm
排除标准
- •o Refusal of procedure or participation in the study.
- •Patient under age of 21years.
- •Infection at site of injection.
- •Psychiatric illness or uncooperative patient.
- •Coagulopathy, use of anticoagulants or antiplatelet therapy.
- •Known allergies to local anesthetics drugs.
- •Uncontrolled glaucoma.
- •Recent surgical procedure on the same eye within one month.
- •Single eyed.
研究组 & 干预措施
Group Dexa
local anesthetic mixture of 4ml Lidocaine hydrochloride-Hyaluronidase plus 4ml Bupivacaine hydrochloride with 4mg Dexamethasone in 1ml normal saline.
干预措施: Dexamethasone (Drug)
Group Mg:
local anesthetic mixture of 4ml Lidocaine hydrochloride-Hyaluronidase plus 4ml Bupivacaine hydrochloride with 50 mg Magnesium sulfate in 1.5ml normal saline.
干预措施: Magnesium sulfate (Drug)
Group C:
Group C: local anesthetic mixture of 4ml Lidocaine hydrochloride-Hyaluronidase plus 4ml Bupivacaine hydrochloride with 2ml normal saline.
干预措施: Bupivacaine hydrochloride (Drug)
结局指标
主要结局
Primary outcome: Time to onset of accepted akinesia score and Need of supplemental injection in each group.
时间窗: 6 months
Primary outcome: Motor blockade (akinesia) will be used as the main index of anesthesia effectiveness. It will be assessed using a 12 point score (12 point akinesia score) as: 0 (no movement), 1 (flicker), 2 (full movement) for the four recti muscles, levator palpebrae and orbicularis oculi (total score 12). Successful block is defined as an ocular motility score between 0 and 6. This score will be compared between the two groups 1, 5 and 10min after injection and at the end of the surgical procedures. The incidence of incomplete blockade (score \>6 after 10min from local anesthetic injection) with a need for supplemental injection will be compared between the two group Time to onset of accepted akinesia score. Need of supplemental injection in each group.
次要结局
- Any perioperative complications will be recorded for each group. Numeric pain scale.(6 months)