A Randomized Comparative Study of Dexmedetomidine Versus Labetalol in Attenuating Airway Stress Response in Hypertensive Patients Undergoing Craniotomy
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Quality of Extubation Assessed Using a Standardized 5-Point Scale
研究概览
简要总结
This randomized trial compares dexmedetomidine and labetalol in controlling airway and hemodynamic stress during extubation in hypertensive patients undergoing craniotomy. Outcomes include extubation quality, vital signs, sedation, and adverse effects.
详细描述
A. Preoperative Settings:
Patients will undergo standard pre-anesthetic assessment, including review of medical history, fasting status, and laboratory investigations. Eligibility will be confirmed based on inclusion and exclusion criteria. After obtaining informed consent, patients will be randomly assigned into two groups using a computer-generated randomization table and sealed envelopes.
B. Intraoperative and Postoperative Settings:
All patients will receive standardized general anesthesia with continuous monitoring. Following completion of surgery and while still under anesthesia, the study drug (either dexmedetomidine or labetalol) will be administered over 10 minutes. Extubation will be performed thereafter.
Hemodynamic parameters including arterial blood pressure and heart rate will be recorded at baseline, during drug administration, and at specific intervals post-extubation. Extubation quality will be assessed using a five-point scale, and sedation levels using the Richmond Agitation-Sedation Scale. Adverse events such as hypotension, bradycardia, or respiratory issues will be documented and managed as per protocol.
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
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 30 and 60 years
- •American Society of Anesthesiologists (ASA) physical status II
- •Diagnosed hypertension
- •Scheduled for elective craniotomy under general anesthesia
- •Able and willing to provide informed consent
排除标准
- •ASA physical status III or IV
- •Uncontrolled comorbidities (e.g., diabetes mellitus)
- •Coagulopathy or current use of anticoagulant or antiplatelet therapy
- •Known allergy or hypersensitivity to dexmedetomidine or labetalol
- •Emergency craniotomy
- •Pregnant or breastfeeding women
- •Patients with a history of severe cardiac arrhythmias
- •Inability to provide informed consent
研究组 & 干预措施
Dexmedetomidine Group
A 50 mL syringe pump containing 0.5 mcg/kg dexmedetomidine diluted with saline to 50 mL will be infused at 300 mL/hr to complete within 10 minutes, followed by extubation.
干预措施: Dexmedetomidine (Drug)
Labetalol Group
A 50 mL syringe pump containing 0.5 mg/kg labetalol diluted with saline to 50 mL will be infused at 300 mL/hr to complete within 10 minutes, followed by extubation.
干预措施: Labetalol (Drug)
结局指标
主要结局
Quality of Extubation Assessed Using a Standardized 5-Point Scale
时间窗: Within the first 5 minutes after extubation
Extubation quality will be assessed immediately after extubation using a standardized 5-point scale, where: 1. = No cough, smooth extubation 2. = Minimal coughing (1-2 times), smooth extubation 3. = Moderate coughing (3-4 times) 4. = Severe coughing (5-10 times) or difficulty breathing 5. = Poor extubation, very uncomfortable, forced breathing (e.g., laryngospasm or coughing \>10 times) A lower score indicates better extubation quality. The outcome will be evaluated by a blinded observer within the first 5 minutes post-extubation.
次要结局
- Sedation Level Post-Extubation(Within 10 minutes after extubation)
- Mean Arterial Pressure (MAP) Variation from Baseline(From baseline (pre-infusion) to 5 minutes post-extubation)
- Heart Rate Variation from Baseline(From baseline (pre-infusion) to 5 minutes post-extubation.)
- Incidence of Adverse Events During and After Extubation(From initiation of drug infusion to 10 minutes post-extubation)