Comparison of Effects of Scalp Block and Intravenous Esmolol on Hemodynamic Response Following the Skull Pins Application for Elective Supratentorial Craniotomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- MAP
研究概览
简要总结
The goal of this clinical trial is to compare hemodynamic response (MAP, SBP, DBP and HR) between scalp block and intravenous esmolol while skull pins application in patients undergoing elective supratentorial craniotomy under general anesthesia.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-65 years old
- •BMI 18-30 kg/m2
- •American Society of Anesthesiologists (ASA) status I-III
- •Elective supratentorial craniotomy under general anesthesia
- •Required application of skull pins
排除标准
- •Poor controlled hypertensive condition (Baseline BP ≥ 160/110 mmHg)
- •Thrombocytopenia / Coagulopathy
- •Preoperative atrioventricular block (More than 2nd degree AV block)
- •Emergency surgery
- •Posterior fossa / Intracranial aneurysm surgery
- •Pregnancy
- •Chronic use of pain control
- •Contraindication to beta-blockers
- •Allergy to the drugs used in the study
研究组 & 干预措施
Group S
Receive 30 ml of 0.25% bupivacaine with 1% lidocaine (1:1) with adrenaline 1:200,000 infiltration for 10 minutes before skull pins application.
干预措施: Scalp block (Procedure)
Group E
Receive intravenous esmolol 1 mg/kg bolus over 1 minute before skull pins application.
干预措施: Esmolol (Drug)
结局指标
主要结局
MAP
时间窗: Baseline, 1 minute before skull pins, then 30 sec, 60 sec, 90 sec, 120 sec, 180 sec and 300 sec after skull pins
Mean arterial pressure
SBP
时间窗: Baseline, 1 minute before skull pins, then 30 sec, 60 sec, 90 sec, 120 sec, 180 sec and 300 sec after skull pins
Systolic blood pressure
DBP
时间窗: Baseline, 1 minute before skull pins, then 30 sec, 60 sec, 90 sec, 120 sec, 180 sec and 300 sec after skull pins
Diastolic blood pressure
HR
时间窗: Baseline, 1 minute before skull pins, then 30 sec, 60 sec, 90 sec, 120 sec, 180 sec and 300 sec after skull pins
Heart rate
次要结局
- BIS(Baseline, 1 minute before skull pins, then 30 sec, 60 sec, 90 sec, 120 sec, 180 sec and 300 sec after skull pins)
- Cumulative postoperative opioids consumption(6 hours and 24 hours postoperatively)
- Postoperative adverse events(Within first 24 hours postoperatively)
研究者
Akkhara Olanvoravuth
Akkhara Olanvoravuth
Khon Kaen University