Hemodynamic Effect of Dexmedetomidine Versus Magnesium Sulphate as an Adjuvant to Lidocaine in Preemptive Peribulbar Block in Patients Undergoing Dacryocystorhinostomy Under General Anesthesia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in mean arterial blood pressure
研究概览
简要总结
This study aims to compare the hemodynamic effect of dexmedetomidine and magnesium sulphate as an adjuvant to lidocaine in preemptive peribulbar block in patients undergoing Dacryocystorhinostomy (DCR) under general anaesthesia (GA) .
详细描述
Dacryocystorhinostomy (DCR) is a delicate ophthalmic surgical procedure aimed at reestablishing the patency of the nasolacrimal duct in patients suffering from nasolacrimal duct obstruction (NLDO).
Magnesium is a non-competitive N-methyl-D-aspartate (NMDA) receptors antagonist, and it can decrease the excitatory post synaptic currents produced by activation of NMDA receptors and it inhibits voltage gated calcium channels.
Dexmedetomidine alpha-2 agonist, which stimulates both central and peripheral alpha-2 receptors which inhibits neuronal firing and inhibits release of C-fibers transmitters such as norepinephrine which inhibits nerve fiber action potential and explains the antinociceptive effects of dexmedetomidine.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Both sexes.
- •American Society of Anesthesiologists (ASA) physical status I or II.
- •Undergoing elective Dacryocystorhinostomy (DCR) surgery under general anesthesia.
排除标准
- •Patients have local infection.
- •Allergic reaction or complications of the local anaesthesia (LA).
- •Coagulopathy defined as international normalized ratio (INR) > 1.5, platelet count < 100,000/mm³, or ongoing anticoagulant therapy not adequately discontinued.
- •Uncontrolled systemic disease, defined as poorly controlled hypertension [systolic blood pressure (SBP) > 160 mmHg], uncontrolled diabetes mellitus (HbA1c > 8.5%), unstable ischemic heart disease, or decompensated hepatic or renal disease.
- •Uncooperative patients.
研究组 & 干预措施
Group A
Patients will receive 5 ml of lidocaine 2% + 50 µg dexmedetomidine, with a total volume of 7 ml.
干预措施: Lidocaine + Dexmedetomidine (Drug)
Group B
Patients will receive 5 ml of lidocaine 2% + 100 mg magnesium sulphate 10%, with a total volume of 7 ml.
干预措施: Lidocaine + Magnesium sulphate (Drug)
Group C
Patients will receive 7 ml of lidocaine 2% with no further additives.
干预措施: Lidocaine (Drug)
结局指标
主要结局
Change in mean arterial blood pressure
时间窗: Till the end of surgery (Up to 2 hours)
The change in mean arterial blood pressure will be recorded at baseline, after induction of anesthesia, immediately before peribulbar block, after block administration, at skin incision, during osteotomy and lacrimal sac manipulation (oculocardiac reflexes-provoking steps), and every 5 minutes thereafter until the end of surgery.
次要结局
- Heart rate(Till the end of surgery (Up to 2 hours))
- Oxygen saturation(Till the end of surgery (Up to 2 hours))
- Degree of patient satisfaction(24 hours postoperatively)
- Degree of surgeon satisfaction(24 hours postoperatively)
研究者
Hebatallah Salah Abdelhamid
Lecturer of Anesthesia, Surgical Critical Care and Pain Management Department, Faculty of Medicine, Cairo University, Cairo, Egypt.
Cairo University