Assessment of the Lowest Effective Dose of Dexmedetomidine in Attenuating the Hemodynamic Responses During Skull Pin Insertion in Patients Undergoing Elective Craniotomy: Randomized Control Study
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- arterial blood pressure change
研究概览
简要总结
Skull pins are used to immobilize the head during craniotomy. Fixation of skull pins causes acute hemodynamic changes which may affect cerebral autoregulation and hence cerebral blood flow. Therefore, maintenance of stable hemodynamic parameters during skull pin placement under general anesthesia is crucial to ensure adequate cerebral perfusion and prevention of acute rise of intracranial pressure
详细描述
Many different strategies have been used to minimize the hemodynamic responses to skull pin placement with varying results. Local anesthetic infiltration at pin application sites has been used but was always unsuccessful in obtunding the hemodynamic responses to skull pin placement. Dexmedetomidine, an alpha-2 adrenoceptor agonist, has been recently introduced as a sedative for patients on mechanical ventilation. In addition to its sedative effect; Dexmedetomidine has significant analgesic qualities and has been labeled as "analgesia-sparing". To the best of the investigator's knowledge, few studies investigated Dex use to suppress hemodynamic responses to skull pinning. The aim of the current study was to evaluate the lowest effective dose of Dexmedetomidine in attenuating the hemodynamic responses to skull pin placement for craniotomies. Lidocaine, administered subcutaneously at the head-holder pin sites, was more effective in preventing the blood pressure response to skull-pin than was deepening the level of anesthesia.
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
- Triple (Participant, Care Provider, Investigator)
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
- 否
入选标准
- •120 Adult patients,
- •undergoing elective craniotomy
- •ASA I and II patients
排除标准
- •patients undergoing craniotomy for emergency surgery,
- •raised ICP,
- •obese patients (body mass index >30 kg/m2 for males and 28 kg/m2 for females),
- •patients having systemic comorbidities (cardiac, renal, hepatic, and endocrinal),
- •hypertensive patients (including those detected after admission),
- •patients undergoing intracranial aneurysm clipping
研究组 & 干预措施
group IV (Dex 0.2)
will receive intravenous Dex 0.2 mcg/kg.
干预措施: Dexmedetomidine Injection [Precedex] (Drug)
group I (placebo)
will receive intravenous normal saline (NS)
干预措施: normal saline 0.9% (Other)
group II (Dex 0.5)
will receive intravenous Dex 0.5 mcg/kg
干预措施: Dexmedetomidine Injection [Precedex] (Drug)
group III (Dex 0.25)
will receive intravenous Dex 0.25 mcg/kg
干预措施: Dexmedetomidine Injection [Precedex] (Drug)
结局指标
主要结局
arterial blood pressure change
时间窗: before Skull Pin Insertion till 20 minutes
systolic and diastolic blood pressure mmhg
heart rate change
时间窗: before Skull Pin Insertion till 20 minutes
heart rate beat/minute
次要结局
未报告次要终点
研究者
Ghada Mohammed AboelFadl
principal investigator
Assiut University
