Comparative Study of Labetalol Infusion Versus Dexmedetomidine Infusion in Hypotensive Anesthesia in Ear, Nose and Throat Surgeries
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Mean arterial blood pressure changes before induction of anesthesia & every 15 min throughout deliberate hypotension
研究概览
简要总结
this study aims to compare between the role of Labetalol infusion versus Dexmedetomidine infusion in hypotensive anesthesia in Ear, Nose and Throat surgeries.
详细描述
Hypotensive anaesthesia is the deliberate lowering of a patient's blood pressure during surgery. It is necessary during ear, nose and throat surgery for drying surgical field, ease in operation procedure and shortening of the duration of surgery. Labetalol is a unique parenteral anti-hypertensive drug that has selective α1 and non- selective β adrenergic antagonist effects. In humans, the β to α blocking potency ratio is 7: 1 for IV labetalol. Dexmedetomidine is highly selective alpha2 adrenergic agonist having several beneficial actions during the perioperative period. Activation of alpha2 adrenergic receptors in the brain and spinal cord inhibits neuronal firing causing hypotension and bradycardia. This study was designed to compare between the role of Labetalol infusion versus Dexmedetomidine infusion in hypotensive anesthesia in Ear, Nose and Throat surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
data collector is also masked in the clinical trial
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists I, II (ASA I, II) patients who were candidate for Ear, Nose and Throat surgeries.
- •Age: between 20 and 50 years
排除标准
- •Patients with uncontrolled hypertension, variable degrees of heart block, congestive cardiac failure, coagulopathy, cerebral insufficiency, hepatic or renal abnormality
- •Patients on beta blocker or clonidine
- •Pregnant or lactating females
- •Patients who were allergic to any of the anesthetic or hypotensive drugs used in the study
- •Patient refusal to be included in the trial
研究组 & 干预措施
Patients undergoing ear, nose and throat surgeries who will receive dexmedetomidine infusion
Dexmedetomidine group: the patients will receive deliberate hypotensive anesthesia with dexmedetomidine infusion (precedex ® 200 μg/2 ml; Hospira, Inc., Rocky Mount, USA) via syringe pump by adding 200 mcg (2ml) of dexmedetomidine to 48 ml of normal saline (final concentration of 4 mcg/ml) The patients will receive a loading dose of 1mcg/kg intravenously followed by an infusion of 0.7 mcg/kg/hour as maintenance dose.
干预措施: Hypotensive anesthesia in ear, nose and throat surgeries using labetalol and dexmedetomidine infusions (Drug)
Patients undergoing ear, nose and throat surgeries who will receive Labetalol infusion
Labetalol groups: the patients will receive deliberate hypotensive anesthesia with labetalol infusion (Labipress 100mg/20ml; Al Debeiky pharma(DBK) pharmaceutical co., Cairo, Egypt) via syringe pump by adding 100 mg (20ml) of Labetalol to 30ml of normal saline (final concentration of 2 mg/ml) The patients will receive a loading dose of 0.4mg/kg intravenously followed by an infusion of 0.04mg/kg/hour as maintenance dose.
干预措施: Hypotensive anesthesia in ear, nose and throat surgeries using labetalol and dexmedetomidine infusions (Drug)
结局指标
主要结局
Mean arterial blood pressure changes before induction of anesthesia & every 15 min throughout deliberate hypotension
时间窗: 12 months
次要结局
- Heart rate changes before induction of anesthesia and every 15 min(12 months)
- Total anesthetic consumption including both inhalational anesthetic consumption and narcotics consumption.(12 months)
- Surgical site oligaemia will be evaluated by the surgeons by rating the amount of bleeding according to Modena bleeding score that provides five different levels (from "Grade 1 - no bleeding" to "Grade 5")(12 months)
- Surgeon satisfaction At the end of the surgery will be evaluated by one surgeon and recorded according to a 5-point Likert scale (5: excellent, 4: Good, 3: Satisfactory, 2: Poor, 1: Very poor)(12 months)